StrataPATH™ (Precision Indications for Approved Therapies): A Study Evaluating the Clinical Activity and Safety of Approved Drugs Within Biomarker-Guided Patients With Solid Tumors
Phase: PHASE2
Conditions: Cancer, Advanced Solid Tumor
Sponsor: Strata Oncology

A STUDY EVALUATING THE CLINICAL 
ACTIVITY AND SAFETY OF APPROVED DRUGS 
WITHIN BIOMARKER-GUIDED PATIENTS WITH 
SOLID TUMORS 
StrataPATH™: Precision Indications for Approved 
Therapies 
Protocol Number: 
STR-004-001 
Version Number:  
2 
Sponsor:   
Strata Oncology® 
Funded by:  
Strata Oncology® 
NCT Identifier:  
NCT05097599 
Date Final: 
version 2, amendment 2 (13-Mar-2023) 
version 1, amendment 1 (19-Aug-2021) 
version 0, original (23-Apr-2021) 
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Amendment 2 (13-Mar-2023) 
The information contained in this protocol and all other information relevant to this study are confidential and 
proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 2 of 56 
 
SUMMARY OF CHANGES  
 
Amendment 2  
Section Header  
Description/ Rationale  
Entire Protocol  
• Updated version and date throughout 
• Added proprietary and confidentiality statement in footer 
• Corrected typos and revised wording to provide clarity as 
appropriate 
• Abbreviation list updated to reflect amendment text 
• Updated reference style for consistency 
Title/ Title Page  
• Added NCT number  
• Added and updated version, amendment and date list 
Investigator Statement 
of Protocol Approval 
• Text size reduced so all fits on 1 page to facilitate investigator’s 
signature 
1.1 Synopsis 
• Updated approval date 
• Updated to reflect other changes made in document 
3.1 Objectives and 
Endpoints 
• Moved molecule response (ctDNA) monitoring from primary to 
secondary objective 
4.3 End of Study 
Definition 
• Clarified end of study definition 
5.1 Inclusion Criteria 
• Clarified that CGP test must be from CLIA certified lab and archival 
tissue needed to confirm CGP results from non-Strata tests or if 
otherwise indicated within a given cohort specific protocol criteria 
5.2 Exclusion Criteria 
• Added multiple primary cancers to exclusions 
• Added primary CNS tumors to exclusions 
• Added negative pregnancy test requirement to ensure women of 
child bearing potential are excluded from study 
5.3 Contraception 
• Added section to provide clarity on contraception use during study 
5.4 Pregnancy  
• Additional text to provide clarity on pregnancy during study 
5.4.1. Use in Nursing 
Women 
• Added section to provide clarity on study drug use in nursing women 
during study 
5.6 Strategies for 
Recruitment and 
Retention 
• Added StrataEXPress screening study to strategies for recruitment 
7.1.1 Study Specific 
Procedures 
• Included Echo with EKG for confirmation of eligibility and clarified 
that Echo and/or EKG may be study procedure if not done as part of 
SOC 
• Clarified additional procedures that are study-specific (i.e. review 
and sign informed consent) 
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Amendment 2 (13-Mar-2023) 
The information contained in this protocol and all other information relevant to this study are confidential and 
proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 3 of 56 
 
7.1.2 Standard of 
Care Procedures 
• Added COVID vaccination and disease history to medical history 
7.2 Study Schedule 
• Added review of medications to baseline and on-treatment visits for 
tdMeta and µMeta cohorts 
9 Statistical 
Considerations 
• Updated information with respect to sample size determination 
• Additional information provided for analysis of some efficacy 
endpoints 
11.6 Safety Oversight 
• Added Data and Safety Monitoring Board (DSMB)  
12.4 Publication and 
Data Sharing Policy  
• Added NCT number 
Cohort Appendices 
All Cohorts: 
• Added Inclusion Criteria to clarify that tumor needs to be measurable 
per RECIST 1.1 criteria  
• Inclusion criteria: ECOG updated to 0-1 from 0-2 
• Review and update Safety Reporting 
 
Cohort A: 
• 
Removed ALK G1202R as a resistance mutation for lorlatinib 
based on current published preclinical and clinical data  
Cohorts D-F: 
• 
Updated biomarker names to be more consistent across cohorts 
Updated Cohort F:  
• Updated excluded tumor types 
• Updated Investigational product overview for conciseness 
• Updated from using Trop2 expression alone to improved model that 
comprises the expression of several genes related to expression of 
the drug antibody target and subsequent release and impact of the 
delivered drug 
• Updated biomarker raitonale 
• Added additional exclusion criteria 
• Updated adverse reactions with information from current package 
inserts 
• Added Cohort G and H  
 
 
 
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Amendment 2 (13-Mar-2023) 
The information contained in this protocol and all other information relevant to this study are confidential and 
proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 4 of 56 
 
 
TABLE OF CONTENTS 
SUMMARY OF CHANGES ....................................................................................................................... 2 
INVESTIGATOR STATEMENT OF PROTOCOL APPROVAL ........................................................... 7 
LIST OF ABBREVIATIONS ...................................................................................................................... 8 
STATEMENT OF COMPLIANCE .......................................................................................................... 11 
1 
PROTOCOL OVERVIEW ............................................................................................................ 12 
1.1 Synopsis .......................................................................................................................................... 12 
1.2 
Study Schematic ................................................................................................................. 16 
2 
INTRODUCTION .......................................................................................................................... 16 
2.1 
Background .......................................................................................................................... 16 
2.2 
Study Rationale ................................................................................................................... 18 
2.3 
Risk/Benefit Assessment ................................................................................................... 18 
3 
OBJECTIVES AND ENDPOINTS .............................................................................................. 19 
3.1 
Objectives and Endpoints .................................................................................................. 19 
3.2 
Study Endpoint Rationale .................................................................................................. 21 
3.2.1 
Real-World Endpoints....................................................................................... 21 
3.2.2 
ctDNA Response Rate ..................................................................................... 22 
3.2.3 
Disease-Free Survival ...................................................................................... 23 
4 
STUDY DESIGN ........................................................................................................................... 23 
4.1 
Overall Design ..................................................................................................................... 23 
4.2 
Justification for Dose .......................................................................................................... 24 
4.3 
End of Study Definition ....................................................................................................... 24 
5 
STUDY ENROLLMENT AND WITHDRAWAL ......................................................................... 24 
5.1 
Inclusion Criteria.................................................................................................................. 24 
5.2 
Exclusion Criteria ................................................................................................................ 25 
5.3 
Contraception ...................................................................................................................... 26 
5.4 
Pregnancy ............................................................................................................................ 26 
5.4.1 
Use in Nursing Women .................................................................................... 26 
5.5 
Screen Failures ................................................................................................................... 27 
5.6 
Strategies for Recruitment and Retention ....................................................................... 27 
5.7 
Participant Discontinuation/Withdrawal from the Study ................................................ 28 
5.8 
Lost to Follow-Up ................................................................................................................ 28 
6 
STUDY AGENTS .......................................................................................................................... 29 
6.1 
Description of Study Agents .............................................................................................. 29 
6.2 
Acquisition and Accountability........................................................................................... 29 
6.3 
Study Agent Compliance ................................................................................................... 29 
6.4 
Study agent Discontinuation .............................................................................................. 30 
7 
STUDY PROCEDURES AND SCHEDULE .............................................................................. 30 
7.1 
Study Procedures................................................................................................................ 30 
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The information contained in this protocol and all other information relevant to this study are confidential and 
proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 5 of 56 
 
7.1.1 
Study Specific Procedures ............................................................................... 30 
7.1.2 
Standard of Care Procedures ......................................................................... 31 
7.2 
Study Schedule ................................................................................................................... 31 
7.2.1 
Schedule of Activities ....................................................................................... 32 
7.2.2 
tdMeta Cohorts .................................................................................................. 35 
7.2.3 
µMeta Cohorts ................................................................................................... 36 
7.3 
Efficacy Assessments ........................................................................................................ 38 
7.3.1 
tdMeta Cohorts .................................................................................................. 38 
7.3.2 
µMeta Cohorts ................................................................................................... 39 
8 
SAFETY ASSESSMENTS AND PROCEDURES .................................................................... 39 
8.1 
Safety and Other Assessments ........................................................................................ 39 
8.2 
Adverse Events and Serious Adverse Events ................................................................ 40 
8.2.1 
Definition of Adverse Events (AE) .................................................................. 40 
8.2.2 
Definition of Serious Adverse Events (SAE) ................................................. 40 
8.2.3 
Classification of an Adverse Event ................................................................. 41 
8.2.4 
Time Period and Frequency for Event Assessment and Follow-Up ......... 42 
8.2.5 
Adverse Event Reporting ................................................................................. 43 
8.2.6 
Serious Adverse Event Reporting .................................................................. 43 
8.2.7 
Reporting Events to Participants .................................................................... 43 
8.2.8 
Events of Special Interest ................................................................................ 43 
8.2.9 
Reporting of Pregnancy ................................................................................... 43 
8.2.10 
Reporting Requirements .................................................................................. 44 
8.3 
Unanticipated Problems ..................................................................................................... 44 
8.3.1 
Definition of Unanticipated Problems (UP).................................................... 44 
8.3.2 
Unanticipated Problem Reporting ................................................................... 45 
9 
STATISTICAL CONSIDERATIONS ........................................................................................... 45 
9.1 
Sample Size Determination ............................................................................................... 45 
9.2 
Populations for Analyses ................................................................................................... 46 
9.3 
Statistical Analyses ............................................................................................................. 47 
9.3.1 
General Approach ............................................................................................. 47 
9.3.2 
Efficacy Analyses .............................................................................................. 47 
9.3.3 
Safety Analyses ................................................................................................. 47 
9.3.4 
Biomarker Analyses .......................................................................................... 48 
9.3.5 
Baseline Descriptive Statistics ........................................................................ 48 
9.3.6 
Planned Interim Analyses ................................................................................ 48 
9.3.7 
Limitations of Analyses..................................................................................... 48 
10 
QUALITY ASSURANCE AND QUALITY CONTROL .............................................................. 48 
10.1.1 
Clinical Monitoring ............................................................................................. 48 
10.1.2 
Quality Assurance and Quality Control .......................................................... 49 
11 
ETHICS/PROTECTION OF HUMAN PARTICIPANTS ........................................................... 49 
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Amendment 2 (13-Mar-2023) 
The information contained in this protocol and all other information relevant to this study are confidential and 
proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 6 of 56 
 
11.1 
Informed Consent Process ................................................................................................ 49 
11.1.1 
Consent/Assent and Other Informational Documents Provided to 
participants………………………………………………………………………………………..…50 
11.1.2 
Consent Procedures and Documentation ..................................................... 50 
11.2 
Study Discontinuation and Closure .................................................................................. 50 
11.3 
Confidentiality and Privacy ................................................................................................ 51 
11.4 
Future Use of Stored Specimens and Data .................................................................... 52 
11.5 
Key Roles and Study Governance ................................................................................... 52 
11.6 
Safety Oversight .................................................................................................................. 52 
12 
DATA HANDLING AND RECORD KEEPING .......................................................................... 53 
12.1 
Data Collection and Management Responsibilities ....................................................... 53 
12.2 
Study Records Retention ................................................................................................... 53 
12.3 
Protocol Deviations ............................................................................................................. 53 
12.4 
Publication and Data Sharing Policy ................................................................................ 54 
13 
CONFLICT OF INTEREST POLICY .......................................................................................... 54 
14 
REFERENCES .............................................................................................................................. 54 
COHORT APPENDICES ........................................................................................................................ 56 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Amendment 2 (13-Mar-2023) 
The information contained in this protocol and all other information relevant to this study are confidential and 
proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 7 of 56 
 
INVESTIGATOR STATEMENT OF PROTOCOL APPROVAL 
STR-004-001 − “Precision Indications for Approved Therapies (StrataPATH): A Study Evaluating the Clinical 
Activity and Safety of Approved Drugs within Biomarker-Guided Patients with Solid Tumors” 
 
The information contained in this protocol and all other information relevant to this study are confidential and proprietary 
information of Strata Oncology Inc., except as may be required by federal, state or local laws or regulation, and may 
not be disclosed to others without prior written permission of Strata. 
 
I have read and I understand protocol STR-004-001 (Amendment 2, DD-Mar-2023) and agree to conduct the study(ies) 
in accordance with the relevant, current protocol(s) and will only make changes in a protocol after notifying the sponsor, 
except when necessary to protect the safety, rights, or welfare of participants. I will conduct this protocol as outlined 
therein and will make all reasonable efforts to complete the study within the designated time and in accordance with all 
national, state, and local laws or regulations. I have read and understand all sections of the protocol. 
 
I agree to personally conduct or supervise the described investigation(s). 
 
I agree to inform any patients, or any persons used as controls, that the drugs are being used for investigational 
purposes and I will ensure that the requirements relating to obtaining informed consent in ICH GCP and institutional 
review board (IRB) review and approval in ICH GCP are met. 
 
I agree to report the sponsor adverse experiences that occur in the course of the investigation(s) in accordance with 
ICH GCP. I have read and understand the information in the investigator’s brochure, including the potential risks and 
side effects of the drug. 
 
I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study(ies) are informed 
about their obligations in meeting the above commitments. 
 
I agree to maintain adequate and accurate records in accordance with ICH GCP and to make those records available 
for inspection in accordance with ICH GCP. 
 
I will ensure that an IRB that complies with the requirements of ICH GCP will be responsible for the initial and continuing 
review and approval of the clinical investigation. I also agree to promptly report to the IRB all changes in the research 
activity and all unanticipated problems involving risks to human participants or others. Additionally, I will not make any 
changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to 
participants.  
 
I agree to comply with all other requirements regarding the obligations of clinical investigators and all other pertinent 
requirements in ICH GCP. 
 
I will provide copies of the protocol and access to all information furnished by Strata to study personnel under my 
supervision. I will discuss material with them to ensure that they are fully informed about the study and study 
procedures. 
 
I understand that the study may be terminated or enrollment suspended at any time by Strata Oncology Inc., with or 
without cause, or by me, if it becomes necessary to do so in the best interests of the study participants. 
 
 
 
____________________________________________________________________________________ 
Investigator Signature 
 
 
 
 
 
 
Date 
 
 
 
____________________________________________________________________________________ 
Investigator Printed Name
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Amendment 2 (13-Mar-2023) 
The information contained in this protocol and all other information relevant to this study are confidential and 
proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 8 of 56 
 
LIST OF ABBREVIATIONS 
ABBREVIATION/TERM 
DESCRIPTION 
µMeta 
Micro-metastatic 
ADR 
Adverse drug reaction 
AE 
Adverse event 
ALK 
Anaplastic lymphoma kinase 
ALT 
Alanine aminotransferase 
AST 
Aspartate aminotransferase 
BRAF 
B-Raf proto-oncogene, serine/threonine kinase 
BUN 
Blood urea nitrogen 
CFR 
Code of Federal Regulations 
CGP 
Complete genomic profile 
CLIA 
Clinical Laboratory Improvement Amendments of 1988 
CMP 
Clinical Monitoring Plan 
CNS 
Central nervous system 
CONSORT 
Consolidated Standards of Reporting Trials 
COVID-19 
Coronavirus disease of 2019 
CR 
Complete response 
CRF 
Case report form 
CT 
Computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
ctDNA 
Circulating tumor DNA 
DFS 
Disease-free survival 
dMMR 
Mismatch repair deficient 
DNA 
Deoxyribonucleic acid 
DSMB 
Data and Safety Monitoring Board 
Echo 
Echocardiogram 
ECOG 
Eastern Cooperate Oncology Group 
EDC 
Electronic data capture 
EGFR 
Epidermal growth factor receptor 
EHR 
Electronic health records 
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Amendment 2 (13-Mar-2023) 
The information contained in this protocol and all other information relevant to this study are confidential and 
proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 9 of 56 
 
EKG 
Electrocardiogram 
ERBB2 
Erb-b2 receptor tyrosine kinase 2 
FDA 
United States Food and Drug Administration 
FFPE 
Formalin-fixed, paraffin-embedded 
GCP 
Good Clinical Practice 
HER2 
Human epidermal growth factor 2 
IB 
Investigator's Brochure 
ICF 
Informed consent form 
ICH 
International Conference on Harmonization 
IEC 
Independent ethics committee 
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
iRECIST 
Response Evaluation Criteria in Solid Tumors in cancer 
immunotherapy trials 
ITT 
Intent to treat 
LDH 
Lactate dehydrogenase 
LVEF 
Left ventricular ejection fraction 
mITT 
Modified intent to treat 
mL 
Milliliter 
MSI 
Microsatellite instability 
MSI-H 
Microsatellite instability-high  
NCI 
National Cancer Institute 
NSCLC 
Non-small cell lung cancer 
NTRK 
Neurotrophic receptor tyrosine kinase 
OHRP 
Office for Human Research Protections 
ORR 
Objective response rate 
OS 
Overall survival 
PD-1 
Programmed death receptor-1 
PD-L1 
Programmed death-ligand 1 
PI 
Principal Investigator 
PR 
Partial response 
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Strata Oncology / STR-004-001 
 
Amendment 2 (13-Mar-2023) 
The information contained in this protocol and all other information relevant to this study are confidential and 
proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 10 of 56 
 
QC 
Quality control 
RECIST 
Response Evaluation Criteria in Solid Tumors 
RNA 
Ribonucleic acid 
rwRR 
Real world response rate 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
SOA 
Schedule of Activities 
SOC 
Standard of care 
SOP 
Standard Operating Procedure 
tdMeta 
Traditionally defined/advanced metastatic 
TIA 
Transient ischemic attack 
TTD 
Time to treatment discontinuation 
TTnT 
Time to next treatment 
UP 
Unanticipated problems 
US 
United States 
VAF 
Variant allele frequency 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Amendment 2 (13-Mar-2023) 
The information contained in this protocol and all other information relevant to this study are confidential and 
proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 11 of 56 
 
STATEMENT OF COMPLIANCE 
The trial will be conducted in accordance with International Conference on Harmonization Good 
Clinical Practice (ICH GCP) and applicable United States (US) Code of Federal Regulations 
(CFR). The Principal Investigator (PI) will assure that no deviation from, or changes to, the 
protocol will take place without prior agreement from the sponsor, funding agency and 
documented approval from the Institutional Review Board (IRB), except where necessary to 
eliminate an immediate hazard(s) to the trial participants. All personnel involved in the conduct 
of this study have completed Human Subjects Protection and ICH GCP Training. 
The protocol, informed consent form(s) (ICFs), recruitment materials, and all participant 
materials will be submitted to the IRB for review and approval. Approval of both the protocol and 
the consent form must be obtained before any participant is enrolled. Any amendment to the 
protocol will require review and approval by the IRB before the changes are implemented to the 
study. All changes to the consent form will be IRB approved; a determination will be made 
regarding whether a new consent needs to be obtained from participants who provided consent, 
using a previously approved form. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Strata Oncology / STR-004-001 
 
Amendment 2 (13-Mar-2023) 
The information contained in this protocol and all other information relevant to this study are confidential and 
proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 12 of 56 
 
1 
PROTOCOL OVERVIEW 
1.1 SYNOPSIS 
Title 
Precision Indications for Approved Therapies (StrataPATH™): A 
Study Evaluating the Clinical Activity and Safety of Approved 
Drugs Within Biomarker-Guided Patients with Solid Tumors 
NCT Identifier 
NCT05097599 
Protocol Number 
STR-004-001 
Sponsor 
Strata Oncology 
Approval Date 
DD-Mar-2023 
Primary Objectives 
Traditionally Metastatic (tdMeta) Cohorts 
• 
Assess the clinical activity of anti-cancer therapies in 
participants with pre-specified biomarker profiles. 
 
Micrometastatic (µMeta) Cohorts 
• 
Evaluate ctDNA response rate at 6 months for participants 
who received an anticancer biomarker-guided therapy. 
Secondary Objectives 
tdMeta Cohorts 
• 
Assess the duration of response in anti-cancer therapies in 
participants with pre-specified biomarker profiles. 
• 
Evaluate ctDNA response rate at additional timepoints for 
participants who received anti-cancer therapies with pre-
specified biomarker profiles. 
• 
Evaluate overall survival (OS) for participants who received 
an anticancer therapy with pre-specified biomarker profiles. 
• 
Monitor and characterize the overall safety for participants 
in each of the biomarker cohorts. 
• 
Assess the molecular response of anti-cancer therapies in 
participants with pre-specified biomarker profiles. 
 
µMeta Cohorts 
• 
Evaluate the ctDNA response rate at additional timepoints 
for participants who receive an anticancer biomarker 
therapy. 
• 
Evaluate disease-free survival (DFS) stratified by ctDNA 
status at different timepoints for participants who receive an 
anticancer biomarker therapy. 
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Amendment 2 (13-Mar-2023) 
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proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 13 of 56 
 
• 
Assess the correlation between ctDNA and Disease-Free 
Survival (DFS). 
• 
Evaluate OS for participants who received an anticancer 
biomarker-guided therapy. 
• 
Monitor and characterize the overall safety for participants 
for participants in each of the biomarker cohorts. 
Exploratory Objective 
tdMeta Cohorts 
• 
Explore the relationship between serial ctDNA 
measurement and participant response to therapy. 
Endpoints 
tdMeta Cohorts 
Primary: 
• 
Objective response rate (ORR) 
Secondary: 
• 
Duration of response (DoR) 
• 
Time to treatment discontinuation (TTD) 
• 
Time to next treatment (TTnT) 
• 
ctDNA response 
• 
Overall survival (OS) 
• 
Incidence of SAEs  
 
µMeta Cohorts 
Primary: 
• 
ctDNA response 
Secondary: 
• 
ctDNA response 
• 
Disease-Free Survival (DFS) 
• 
Overall survival (OS) 
• 
Incidence of SAEs 
Study Description 
StrataPATH is a non-randomized, open-label platform study 
designed to explore the efficacy and safety of multiple FDA-
approved and commercially available cancer therapies in new, 
biomarker-guided patient populations. This study intends to rapidly 
identify participants which have efficacy signals for possible 
expansion into adaptive or randomized studies. As this is a 
platform study, drug/biomarker cohorts may be added, changed, or 
discontinued over time. 
 
Eligible participants (> 18 years age) are those with a historically 
documented/pathologically confirmed solid tumor, have an eligible 
biomarker profile, and are planned for treatment. Study procedures 
will include: CT or MRI imaging (if enrolled in the tdMeta cohort) 
and repeat blood draws to support ctDNA assessment; study drug 
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Amendment 2 (13-Mar-2023) 
The information contained in this protocol and all other information relevant to this study are confidential and 
proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 14 of 56 
 
dispensation, administration, and accountability; and data 
collection of standard of care procedures that may be done at 
regular clinic visits. 
Study Population 
35 participants per cohort for 20 cohorts (700 participants total) 
 
Inclusion Criteria: 
1. Male or female > 18 years of age. 
2. Pathologically confirmed solid tumor.  
3. Participants must be able to follow study visit schedule and 
be willing to provide peripheral blood samples at the 
indicated time points. 
4. CGP results need to be from a test conducted in a CLIA 
approved laboratory and archival formalin-fixed, paraffin-
embedded (FFPE) tumor tissue is required for confirmatory 
testing of non-Strata test results unless otherwise indicated 
within the cohort-specific protocol criteria. 
5. Biomarker positive for the defined cohort.  
6. Individuals with non-primary,treated or stable brain 
metastases must show no radiographic evidence of 
progression within 4 weeks prior to consent. 
7. Adequate bone marrow, organ function & laboratory 
parameters as determined by the treating physician unless 
otherwise indicated within the cohort-specific protocol 
criteria. 
8. Adequate cardiac function: 
a. Left ventricular ejection fraction (LVEF) ≥ 50%. 
b. QTc interval ≤ 470 ms (females) or ≤ 450 ms 
(males) average preferred. 
 
Exclusion Criteria: 
• 
Receiving another anticancer therapy. 
• 
Major surgery within 4 weeks prior to study entry. 
• 
Has received a systemic anticancer therapy within 3 weeks 
of first study dose. 
• 
Individuals with a history of a second malignancy are ineligible 
except for the following circumstances:  
a. Individuals with a history of other malignancies are 
eligible if they have been disease-free for at least 3 years 
or are deemed by the investigator to be at low risk for 
recurrence of that malignancy.  
b. Individuals with the following cancers that have been 
diagnosed and treated within the past 3 years are 
eligible: cervical/prostate carcinoma in situ, superficial 
bladder cancer, non-melanoma cancer of the skin. 
c. Patients with other cancers diagnosed within the past 3 
years and felt to be at low risk of recurrence should be 
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proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 15 of 56 
 
discussed with the study principal investigator to 
determine eligibility. 
• 
Participant has a primary central nervous system system 
tumor. 
• 
A woman of childbearing potential who has a positive urine 
pregnancy test (within 72 hours) prior to treatment. If the urine 
test is positive or cannot be confirmed as negative, a serum 
pregnancy test will be required.  
• 
Females who are pregnant or nursing or plan to become 
pregnant or anyone unwilling to use contraception for the 
duration of treatment. 
• 
Ongoing toxicity of CTCAE grade >2, other than peripheral 
neuropathy, related to anticancer therapy that was 
completed within 4 weeks of consent. 
• 
Ongoing peripheral neuropathy of CTCAE grade >3 
• 
History of stroke including transient ischemic attack (TIA) or 
acute myocardial infarction within 6 months of consent. 
• 
Participant has a known history of human 
immunodeficiency virus (HIV), Hepatitis B or known active 
Hepatitis C virus infection. 
• 
Medical condition that would place the patient at risk as a 
result of blood donation, such as bleeding disorder. 
• 
Any other clinically significant medical condition that, in the 
opinion of the treating physician, makes participation undesirable, 
including but not limited to ongoing or active infection, significant 
uncontrolled hypertension, or severe psychiatric illness. 
Study Duration 
Approximately 5 years 
Participant Duration 
Up to 3 years 
Description of 
Enrolling Sites 
25-30 sites 
Description of Study 
Intervention 
The description of each cohort/study drug is included in the 
appendix. 
 
 
 
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1.2 STUDY SCHEMATIC 
The study schema is outlined in Figure 1 below.  
 
Figure 1: Study Schematic for StrataPATH 
 
 
 
2 
 
INTRODUCTION 
2.1 BACKGROUND  
Cancer continues to be a significant cause of human disease, with an estimated 1.8 million new 
cancer cases diagnosed in the United States (US) in 2019.1 Although survival rates vary widely 
across cancer types and disease stage, 5-year survival is approximately 68% across all cancer 
types.2 When the disease can be diagnosed in the early-stage, standard adjuvant therapy 
following definitive therapy contributes to 5-year survival rates surpassing 90% (in select cancer 
types). It is estimated that there are 5.5 million patients living with cancer in the US that would 
have been diagnosed within the past 5 years. Many of these patients progress to late-stage 
cancer with over 600,000 deaths each year. As the second leading cause of US deaths, 
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identifying improved cancer treatment methods, is critical in reducing the extreme burden placed 
on patients, their families, health care systems, and society.1 
 
The goal of precision medicine is to treat individuals based on the combination of their clinical 
and molecular characteristics resulting in an improved clinical benefit compared to standard or 
generic anticancer therapies. Pan-tumor targeted therapies are designed to focus on specific 
genomic changes rather than a site of origin. Identifying the precise set of patients who are most 
likely to respond to pan-tumor targeted therapies requires significant investment and motivation 
as the frequencies of particular genomic changes are low. This poses a challenge to the 
traditional model of drug development. Despite these challenges, precision therapies have seen 
some recent success. For example, some treatments previously approved for mutations in 
single tumor types (e.g., HER2 [ERBB2] gene amplification in breast, BRAF mutations in 
melanoma, EGFR mutations and ALK translocations in lung) have broadened to pan-tumor 
approvals.  
 
In 2017, the United States Food and Drug Administration (FDA) approved the first tumor-
agnostic (or pan-tumor) indication in oncology. Pembrolizumab was approved for adult and 
pediatric patients with unresectable, microsatellite instability-high (MSI-H) or mismatch repair 
deficient (dMMR) solid tumors who have progressed following prior treatment and who have no 
satisfactory treatment options. Efficacy was based on data from 149 patients enrolled across 
five uncontrolled trials. Overall response rate (ORR) was 39.6% (95%CI 31.7-47.9), including 11 
complete responses and 48 partial responses.3 Microsatellite instability (MSI) is estimated to 
occur in 3-5% of all solid tumors.4 
 
Larotrectinib was approved in November of 2018. This precision therapy targets adult and 
pediatric solid tumors which have neurotrophic receptor tyrosine kinase (NTRK) fusions that are 
metastatic or where surgical resection is likely to result in severe morbidity, and who have no 
satisfactory alternative treatments or whose cancer has progressed following treatment. Efficacy 
was based on 55 patients treated across 3 different trials spanning 12 cancer types. ORR was 
75% (95%CI: 61%-85%), including 22% complete responses and 53% partial responses.5 While 
the clinical benefit is substantial and durable, NTRK fusions are also very rare occurring in less 
than 1% of most tumors. 
 
While these study results are impressive, the reality is that only a fraction of eligible patients 
receive targeted therapies, and not until the overt metastatic stage when the potential for a cure 
may be improbable. There have been efforts to move these precision medicines earlier in the 
disease stage. For example, the EGFR inhibitor osimertinib, which is FDA approved for use in 
treatment naïve advanced non-small cell lung cancer (NSCLC), was tested for efficacy in 
patients with EGFR-mutated stage IB to IIIA NSCLC in the ADAURA trial.6 Patients were 
randomized to receive either osimertinib or placebo. Patients in the treatment group had 
significantly longer disease-free survival (DFS) compared to patients in the placebo group (HR = 
0.18; 95% CI 0.10 to 0.33).6 The population was pre-selected based on biomarker status, and 
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patients were treated with osimertinib as adjuvant therapy. The data demonstrates the potential 
benefit of moving targeted therapies to earlier disease states.  
 
Importantly, 44% of patients treated with placebo in ADAURA had not recurred after 24 months. 
In the paradigm of treating all early-stage patients with EGFR-mutant NSCLC with osimertinib, a 
substantial proportion may be cured prior to osimertinib treatment, and hence, cannot derive 
benefit while being exposed to osimertinib for 2 years. This indicates an opportunity to leverage 
newer technologies – specifically, liquid biopsies – to explore and refine who should be treated 
with targeted therapies based on if circulating tumor cells are present in the blood post-surgery.  
 
With advancements in both tissue and blood-based molecular technologies, including genomic 
and transcriptomic profiling, there is an opportunity to expand the clinical benefit of approved 
therapies to earlier in the disease process where there is improved opportunity for durable 
disease-free survival. 
 
2.2 STUDY RATIONALE  
The cancer patient’s treatment journey varies widely and is determined by stage and tumor type 
at diagnosis. Technology advances over the last few decades have provided physicians with 
improved information to better tailor patient treatment. These technologies now allow us to 
understand: 1) if genomic evidence of tumor cells remain in the blood after surgery; 2) how a 
tumor’s genetic and transcriptomic make-up might impact a patient’s response to therapy; and 
3) if a personalized therapy is reducing disease burden.  
 
StrataPATH is a non-randomized, open-label trial designed to explore efficacy and safety of 
multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided 
patient populations. Aiming to increase clinical benefit for patients, this study will leverage 
technology advancements, scientific literature, and Strata’s real-world evidence to define novel, 
highly responsive pan-tumor molecular indications for FDA-approved therapies in both the 
advanced and micro-metastatic settings. Strata will rapidly identify participants who have 
efficacy signals for possible expansion into adaptive or randomized studies. 
 
StrataPATH is a platform study intended to study participants in both the overt metastatic setting 
and the circulating tumor deoxyribonucleic acid (ctDNA)-positive micro-metastatic setting. Due 
to potential population differences including, but not limited to, disease stage, Eastern 
Cooperate Oncology Group (ECOG) status, age, and prior treatments, these cohorts will be 
studied separately by design and in data analysis using different study endpoints.  
 
2.3 RISK/BENEFIT ASSESSMENT 
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This study will evaluate the clinical benefit of existing FDA-approved therapies for off-label 
indications. Participants included in the measurable disease cohorts will have advanced or 
metastatic cancer that has progressed following standard therapy, have not adequately 
responded to standard therapy, have no existing standard therapy, have declined standard 
therapy, or, in the opinion of the Investigator, are not a candidate for or would be unlikely to 
tolerate or derive significant clinical benefit from standard therapy. These patients have limited 
to no treatment options, and the potential to select for an improved responder population based 
on known biomarkers within the drug class with plausible biologic rationale may provide tumor 
reduction and clinical benefit.  
 
This study may also include separate cohorts of patients in the micro-metastatic setting (as 
defined by ctDNA positive liquid biopsy) post-standard of care adjuvant therapy, but not yet 
having been identified as traditionally advanced or metastatic using standard of care imaging or 
biochemical testing. All therapies are FDA-approved in oncology with demonstrated safety 
profiles in the traditionally advanced setting; the toxicity profile may be different in the micro-
metastatic setting. The utility of targeted therapy in the early-stage setting has been 
demonstrated with the approval of osimertinib for patients with EGFR-mutated NSCLC. The 
ADAURA trial demonstrated that osimertinib was well tolerated post-resection in patients with 
stage IB-III NSCLC; dose reductions due to adverse events occurred in 9% of patients in the 
treatment group.6 This was comparable to the 10% dose reduction rate observed in first-line 
patients with advanced NSCLC at the same recommended dose.7 Comparatively, the toxicity 
profile of immunotherapies in early-stage disease may not be as favorable. Dose 
discontinuation due to adverse events occurred in only 9% of patients with advanced melanoma 
treated with pembrolizumab in KEYNOTE-001, while 14% of melanoma patients that received 
pembrolizumab as adjuvant therapy post resection in KEYNOTE-054 experienced adverse 
event related dose discontinuation.8,9 Recently announced data from KEYNOTE-564, however, 
suggests that the toxicity profile of pembrolizumab when used as adjuvant therapy in patients 
with renal cell carcinoma following nephrectomy was consistent with previously reported studies 
with the anti-PD-1 therapy.10 To monitor risk and capture any differences in toxicity profiles 
between patient populations, full safety data collection will be collected in this study.  
 
More information on the clinical data associated with each therapeutic study arm and known 
and expected benefits, risks, and reasonably expected adverse events (Aes) may be found in 
the corresponding appendices. 
 
3 
OBJECTIVES AND ENDPOINTS 
3.1 OBJECTIVES AND ENDPOINTS 
All endpoints will be assessed independently for each biomarker-defined cohort. Tables A and 
B list the objectives and endpoints for this study. Cohorts are stratified based on disease 
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severity: (1) traditionally defined metastatic/advanced (tdMeta), and (2) micro-metastatic 
(µMeta). 
 
Table A: StrataPATH Objectives and Endpoints for tdMeta Cohorts 
tdMeta Cohorts 
OBJECTIVES 
ENDPOINTS 
Primary 
Assess the clinical activity of anti-
cancer therapies in participants with 
pre-specified biomarker profiles.  
ORR – Overall Response Rate is defined as the percentage of 
participants with a best overall response of CR or PR based on 
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, 
as assessed by the investigator. 
Secondary 
Assess the duration of response in 
anti-cancer therapies in participants 
with pre-specified biomarker profiles.  
• DoR – Duration of response is defined as the time from first 
documentation of disease response (CR or PR) until first 
documentation of progressive disease.  
• TTD – Time to treatment discontinuation is defined as 
length of time from the date the participant initiates the 
systemic treatment to the date the participant discontinues 
treatment  
• TTnT – Time to next treatment is defined as the length of 
time from the date the participant initiates study treatment 
to the date the participant initiates their next systemic 
treatment or death. 
Evaluate ctDNA response rate at 
timepoints for participants who 
received anti-cancer therapies with 
pre-specified biomarker profiles. 
ctDNA response – Proportion of participants with a <50% ratio 
of mean VAF will be defined as ctDNA responders. Molecular 
response is calculated as a ratio of mean VAF on-treatment at 
different timepoints compared to their baseline VAF. 
Evaluate overall survival (OS) for 
participants who received an 
anticancer therapy with pre-specified 
biomarker profiles. 
OS – Time from initiation of treatment until death from any 
cause. 
Monitor and characterize the overall 
safety in the biomarker cohorts 
The incidence of serious adverse events (SAEs). 
Exploratory 
Explore the relationship between serial 
ctDNA measurement and participant 
response to therapy.  
N/A 
 
Table B: StrataPATH Objectives and Endpoints for µMeta Cohorts 
µMeta Cohorts 
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OBJECTIVES 
ENDPOINTS 
Primary 
Evaluate ctDNA response rate at 6 months for 
participants who received an anticancer biomarker-
guided therapy. 
ctDNA response – Proportion of participants with a 
<50% ratio of mean VAF will be defined as ctDNA 
responders. Molecular response is calculated as a 
ratio of mean VAF on-treatment at 6 months 
compared to their baseline VAF. 
Secondary 
Evaluate the ctDNA response rate at additional 
timepoints 
for 
participants 
who 
receive 
an 
anticancer biomarker therapy. 
ctDNA response – Proportion of participants with a 
<50% ratio of mean VAF will be defined as ctDNA 
responders. Molecular response is calculated as a 
ratio of mean VAF on-treatment at additional 
timepoints compared to their baseline VAF. 
Evaluate Disease-Free Survival (DFS) stratified by 
ctDNA status or response at different timepoints. 
DFS – Time from initiation of treatment until disease 
recurrence or death from any cause. 
Assess the correlation between ctDNA and 
Disease-Free Survival (DFS). 
DFS – Time from initiation of treatment until disease 
recurrence or death from any cause. 
Evaluate overall survival (OS) for participants who 
received an anticancer biomarker-guided therapy. 
OS – Time from initiation of treatment until death 
from any cause. 
Monitor and characterize the overall safety for 
participants in the biomarker cohorts 
Incidence of serious adverse events (SAEs). 
 
 
3.2 STUDY ENDPOINT RATIONALE 
Study endpoints are stratified by disease severity (tdMeta or µMeta). Study endpoints include 
traditionally accepted trial endpoints in single-arm oncology studies including objective response 
rate (ORR), duration of response (DoR), disease-free survival (DFS), and overall survival 
(OS)11. The study also leverages real-world endpoints of time to next treatment (TTnT) and time 
to treatment discontinuation (TTD), and another potential surrogate endpoint of ctDNA response 
rate as defined in Table A and further described below.  
3.2.1 REAL-WORLD ENDPOINTS 
Increasingly, real-world evidence is being looked to as a complement to traditional clinical trial 
data collection. Real-world data is often easier and less expensive to collect, especially if it can 
be exported directly from electronic health record systems. The 21st Century Cures Act 
mandates the creation of regulatory pathways to support real-world evidence based regulatory 
approvals for the expanded use of existing FDA-approved therapies. For this study, we sought 
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to leverage both traditional and real-world data collection methodologies to reduce future data 
collection burden.  
 
OS is well established as a standard measure of clinical benefit in cancer drug development. 
Additionally, surrogates are often used to support drug and/or medical device development as 
they have reduced event timelines. The changes “induced by a therapy on a surrogate endpoint 
are expected to reflect changes in a clinically meaningful endpoint”.12  
 
TTnT and TTD will additionally be used as potential surrogates to OS. Khozin and colleagues 
looked at programmed death-ligand 1 (PD-L1) therapy outcomes for NSCLC participants within 
the Flatiron dataset and found that overall survival was strongly correlated with real world TTD 
(r2=0.81, 95% CI 0.80-0.82) and also modestly correlated with TTnT (p = 0.60, 95% CI 0.56-
0.64).13 Similar results were observed across six different datasets (N=269-6,924) for NSCLC 
participants treated with immunotherapies. Correlations between the real-world endpoints of 
real-world TTD and real-world TTnT and OS were moderate to high and the authors concluded 
“real-world end points are generally consistent with each other and with outcomes observed in 
randomized clinical trials, which substantiates the potential validity of real-world data to support 
regulatory and payor decision making”.14 
 
As high and significant correlation does not necessarily capture off-target effects and does not 
equal causation, Prentice has posited that it may be sufficient if the surrogate captures the net 
effect of the intervention on the clinical efficacy measure.15 OS inherently captures not only the 
study drug’s efficacy, but also any downstream therapies the participant might have been 
administered.13 Real-world TTnT and real-world TTD may provide more clinically meaningful 
endpoints as they also take into account why physicians and participants alter clinical care 
including toxicity and efficacy of the current drug under study. These surrogates are censored 
less commonly compared to OS.14 While we may not have a comprehensive understanding of 
all factors, the most reliable evidence regarding the validity of a surrogate endpoint for a clinical 
efficacy measure might be provided by numerous trials which give reliable estimates of the net 
effects of the intervention on the clinically meaningful endpoint such as overall survival and the 
surrogate.16 As in previous studies, this study will assess both the proposed surrogates (real-
world TTNT and real-world TTD) and the known clinically meaningful endpoint of OS for the 
primary objectives.  
3.2.2 CTDNA RESPONSE RATE 
ctDNA clearance or response has been shown to be an early predictor of therapy response.17,18 
The current study will leverage ctDNA response rate as the secondary endpoint in both tdMeta 
and µMeta cohorts. ctDNA response rate is defined as the proportion of participants with a 
<50% ratio of mean VAF. An individual’s molecular response is calculated as a ratio of mean 
VAF on-treatment at 6 months to their baseline VAF. This is based on the tracer markers based 
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on the personalized ctDNA assay which are averaged together to create a mean VAF. Any 
participant who has a <50% ratio is defined as a responder. 
3.2.3 DISEASE-FREE SURVIVAL 
Disease-free survival (DFS) is defined as the time from date of first dose until disease 
recurrence or death from any cause. The most frequent use of this endpoint is in the adjuvant 
setting after definitive surgery or radiotherapy and is a recommended clinical endpoint based on 
FDA’s guidance Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.11 
 
4 
STUDY DESIGN  
4.1 OVERALL DESIGN  
Participants who are 18 years of age or older, have been diagnosed with histologically 
documented solid tumors, have an eligible biomarker profile, and are planned for treatment may 
be eligible for this study according to the criteria in Sections 5.1-5.2 and the supplemental 
criteria in the specific biomarker/drug cohort appendix.  
 
Each biomarker/drug cohort will be described in an appendix to this study protocol. Appendix 
information includes investigational product overview, rationale for biomarker/drug combination, 
additional cohort-specific eligibility criteria, study treatment including dosing and administration 
guidelines, along with known adverse reactions.  
 
After obtaining informed consent, study staff shall assess individual participant eligibility using 
the criteria in Sections 5.1-5.2 and the supplemental criteria in the specific appendix they are 
targeting for enrollment. The designated study staff will enter the participant’s details into the 
electronic data capture (EDC) to support a sponsor-required confirmation of biomarker eligibility. 
Upon confirmation of eligibility and informed consent procedures, the participant will be formally 
enrolled into the study. Participants will be treated with the applicable cohort’s study drug 
according to dosing instructions in the approved product labeling or provided Investigator’s 
Brochure (IB).  
 
For participants who exhibit more than 1 eligible biomarker result, the treating physician should 
determine the most appropriate cohort assignment. Factors for consideration include the drug’s 
dosing and administration guidelines, as well as the commercially available product prescribing 
instructions or provided IB. 
 
A leftover tumor specimen (if historical comprehensive genomic profiling (CGP) and/or 
ribonucleic acid (RNA) profiling results are not available for submission) and blood sample for 
ctDNA analysis will be collected at study entry (prior to therapy start). Blood samples will be 
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collected and CT/MRI scans will be performed until treatment discontinuation as outlined in the 
Study Schedule of Activities (SOA) (Section 7.2).  
 
Tumor assessments to support ORR efficacy assessment will be completed as outlined in the 
Study Schedule of Activities (Section 7.2) and recorded in the study database. Study staff will 
also record information in the study EDC (either manually or through an integrated mechanism) 
which occur as part of standard of care visits. Standard of care details such as demographics, 
clinical characteristics, and concomitant medications will be recorded within the study database. 
Upon identification of any efficacy signal, additional real-world data collection may be requested 
(i.e., additional medical history and imaging) to support additional analysis and cohort expansion 
studies. Following completion of or discontinuation from drug, all active study participants will be 
followed for survival for 3 years from the date of consent.  
 
This study will require reporting of Common Terminology Criteria for Adverse Events (CTCAE) 
grade 3 and 4 Aes that are possibly, probably, or definitely related to the study treatment. All 
SAEs, regardless of grade, relatedness to study drug, or expectedness, must be reported, 
including deaths.  
 
Drug/biomarker cohorts may be added, changed, or discontinued over time. This study may 
enroll up to 700 participants.  
 
4.2 JUSTIFICATION FOR DOSE 
Each drug will be administered according to the FDA-approved dosing regimen listed in the 
approved product labeling or provided Investigator’s Brochure (IB). 
 
4.3 END OF STUDY DEFINITION 
A participant is considered to have completed the study if they were treated for any duration of 
time, and were followed for survival for 3 years from the date of consent or until death. 
 
5 
STUDY ENROLLMENT AND WITHDRAWAL 
5.1 INCLUSION CRITERIA 
To be eligible to participate in this study, an individual must meet each of the criterion below 
and the criteria indicated in the selected biomarker/drug cohort appendix: 
1. Male or female > 18 years of age. 
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2. Pathologically confirmed solid tumor.  
3. Participants must be able to follow study visit schedule and be willing to provide 
peripheral blood samples at the indicated time points. 
4. CGP results need to be from a test conducted in a CLIA approved laboratory and 
archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue is required for 
confirmatory testing of non-Strata test results unless otherwise indicated within the 
cohort-specific protocol criteria. 
5. Biomarker positive for the defined cohort.  
6. For individuals with non-primary, treated or stable brain metastases: No evidence of 
progression (defined as no radiographic evidence of progression) for at least 4 weeks 
prior to consent. 
7. Adequate bone marrow, organ function & laboratory parameters as determined by the 
treating physician unless otherwise indicated within the cohort-specific protocol criteria. 
8. Adequate cardiac function: 
8.1. Left ventricular ejection fraction (LVEF) ≥ 50% 
8.2. QTc interval ≤ 470 ms (females) or ≤ 450 ms (males) average preferred. 
5.2 EXCLUSION CRITERIA 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
1. Receiving another anticancer therapy. 
2. Major surgery within 4 weeks prior to study entry. 
3. Has received a systemic anticancer therapy within 3 weeks of first study dose. 
4. Individuals with a history of a second malignancy are ineligible except for the following 
circumstances. Individuals with a history of other malignancies are eligible if they have 
been disease-free for at least 3 years or are deemed by the investigator to be at low risk 
for recurrence of that malignancy. Individuals with the following cancers that have been 
diagnosed and treated within the past 3 years are eligible: cervical/prostate carcinoma in 
situ, superficial bladder cancer, non-melanoma cancer of the skin. Patients with other 
cancers diagnosed within the past 3 years and felt to be at low risk of recurrence should 
be discussed with the study principal investigator to determine eligibility. 
5. Participant has primary central nervous system tumor. 
6. A woman of childbearing potential who has a positive urine pregnancy test (within 72 
hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, 
a serum pregnancy test will be required.  
7. Females who are pregnant or nursing or plan to become pregnant or anyone unwilling to 
use contraception for the duration of treatment. 
8. Ongoing toxicity of CTCAE grade >2, other than peripheral neuropathy, related to 
anticancer therapy that was completed within 4 weeks of consent. 
9. Ongoing peripheral neuropathy of CTCAE grade >3. 
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10. History of stroke including transient ischemic attack (TIA) or acute myocardial infarction 
within 6 months of consent. 
11. Participant has a known history of human immunodeficiency virus (HIV), Hepatitis B or 
known active Hepatitis C virus infection. 
12. Medical condition that would place the patient at risk as a result of blood donation, such 
as bleeding disorder. 
13. Any other clinically significant medical condition that, in the opinion of the treating 
physician, makes participation undesirable, including but not limited to ongoing or active 
infection, significant uncontrolled hypertension, or severe psychiatric illness. 
 
5.3 CONTRACEPTION 
Study medication may have adverse effects on a fetus in utero. Furthermore, it is not known if 
study medication has transient adverse effects on the composition of sperm.  
Participants should be informed that taking the study medication may involve unknown risks to 
the fetus (unborn baby) if pregnancy were to occur during the study. In order to participate in the 
study, participants of childbearing potential must adhere to the contraception requirement from 
the day of study medication initiation (or 14 days prior to the initiation of study medication for 
oral contraception) throughout the study period up to 210 days after the last dose of study 
medication. Please refer to the cohort specific package insert for information on contraception 
requirements. If there is any question that a participant of childbearing potential will not reliably 
comply with the requirements for contraception, that participant should not be entered into the 
study. 
 
5.4 PREGNANCY 
If a participant inadvertently becomes pregnant while on treatment with study medication, the 
participant will be immediately discontinued from study treatment. The site will contact the 
participant at least monthly and document the participant’s status until the pregnancy has been 
completed or terminated. The outcome of the pregnancy will be reported to the Sponsor without 
delay and within 24 hours if the outcome is a serious adverse event (e.g., death, abortion, 
congenital anomaly, or other disabling or life-threatening complication to the mother or 
newborn). The study investigator will make every effort to obtain permission to follow the 
outcome of the pregnancy and report the condition of the fetus or newborn to the Sponsor. 
5.4.1 USE IN NURSING WOMEN 
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It is unknown whether study medication is excreted in human milk. Since many drugs are 
excreted in human milk, and because of the potential for serious adverse reactions in the 
nursing infant, participants who are breastfeeding are not eligible for enrollment. 
 
5.5 SCREEN FAILURES 
Screen failures are defined as individuals who consented to participate in the clinical trial but 
were not subsequently entered in the study. A minimal set of screen failure information is 
required to ensure transparent reporting of screen failure participants, to meet the Consolidated 
Standards of Reporting Trials (CONSORT) publishing requirements and to respond to queries 
from regulatory authorities. Minimal information includes demography, screen failure details, 
eligibility criteria, and any serious adverse event (SAE). 
 
Individuals who do not meet the criteria for participation in this trial (screen failure) because of 
the following may be considered for re-screening: 
• 
Reversible causes of screening failure that have been adequately treated. 
• 
Performance status. 
• 
Stage of disease did not meet inclusion criteria at initial screen but have since 
progressed and may now meet eligibility criteria. 
• 
Decline or delay in starting due to change in situation (availability, family situation, etc.). 
Re-screened participants should be assigned the same study ID number as the initial screening 
(i.e., re-screened participants do not receive new study IDs). 
 
5.6 STRATEGIES FOR RECRUITMENT AND RETENTION 
Individuals will be screened and molecularly identified through standard of care (SOC) CGP 
testing or other available RNA profiling tests. StrataPATH will leverage the Strata Precision 
Oncology Network, a collective of >20 large hospital systems in the United States in addition to 
other academic and large research institutions familiar with biomarker-driven studies. Using this 
systematized approach, the pre-screened study population will be more likely to represent the 
demographics of the general advanced cancer population.  
 
StrataEXPress (NCT05312307) is a parallel screening study that will be used to identify patients 
with RNA expression profiles or relevant algorithm scores consistent with eligibility requirements 
for StrataPATH biomarker/drug treatment cohorts. For StrataEXPress, archival tissue from solid 
tumors will be collected from eligible participants for RNA expression analysis using next-
generation sequencing. 
 
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Page 28 of 56 
 
As many of these biomarkers are rare, other testing modalities are acceptable, if, sufficient 
detail is provided to support sponsor eligibility confirmation. 
 
Pregnant women, those who lack consent capacity, including the mentally ill, prisoners, 
cognitively impaired participants, children, and employee volunteers will not be included in this 
study. 
 
Participants will generally be seen and assessed for this research study during their regular 
clinic visits, reducing the burden to participants and their families.  
 
5.7 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon request. 
 
An investigator may discontinue or withdraw a participant from the study for any of the following 
reasons: 
• 
Pregnancy. 
• 
Significant study intervention non-compliance.  
• 
If any clinical AE, laboratory abnormality, or other medical condition or situation occurs 
such that continued participation in the study would not be in the best interest of the 
participant. 
• 
Disease progression which requires discontinuation of the study intervention. 
• 
If the participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation. 
• 
Participant unable to receive therapy for greater than 2 weeks. 
• 
Death. 
The reason for participant discontinuation or withdrawal from the study will be recorded on the 
CRF. Participants who sign the ICF but do not receive the study intervention may be replaced. 
Participants who sign the ICF, receive the study intervention, and subsequently withdraw, or are 
withdrawn or discontinued from the study, will be replaced if the reason for withdrawal is not due 
to failure to respond. Any participants who withdraw due to progression will be counted in 
efficacy calculations. Any participant withdrawal and replacement will be detailed in the 
Screening and Enrollment Log.  
 
5.8 LOST TO FOLLOW-UP 
A participant will be considered lost to follow-up if they fail to return for 2 consecutively 
scheduled visits and are unable or unwilling to be contacted by the study site staff.  
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The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
• 
The site will attempt to contact the participant and reschedule the missed visit within a 
week and counsel the participant on the importance of maintaining the assigned visit 
schedule and ascertain if the participant wishes to and/or should continue in the study. 
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make 
every effort to regain contact with the participant (where possible, 3 telephone calls and, 
if necessary, a certified letter to the participant’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the participant’s 
medical record or study file.  
• 
Should the participant continue to be unreachable, they will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
 
6 
STUDY AGENTS 
6.1 DESCRIPTION OF STUDY AGENTS 
Each specific drug/biomarker cohort appendix will describe study drug dosing and 
administration, any preparation and handling requirements separately.  
 
6.2 ACQUISITION AND ACCOUNTABILITY 
The study will utilize a combination of local pharmacy and central drug depot that will house and 
distribute all study drug on a per patient basis. Drug will be unblinded. Treatment cohort is 
determined by biomarker test results and will be communicated directly by Strata to the depot. 
When the central drug depot is used, study drug will be shipped from the drug depot of record to 
the study site. Visual confirmation of the shipment will be conducted by the PI or designee and 
documented according to the operations manual.  
 
6.3 STUDY AGENT COMPLIANCE 
Drug accountability will be performed by delegated study staff. The delegated study staff is 
responsible for ensuring that the participant is dosed according to the package insert. For 
applicable cohorts where participants are taking study drugs outside of the clinic, participants 
will be instructed to return all unused drug and empty packaging for accountability assessment. 
Used drug may be destroyed on site if sites SOPs support or returned to the drug depot. Details 
are outlined in the operations manual. 
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Page 30 of 56 
 
 
6.4 STUDY AGENT DISCONTINUATION 
Discontinuation of dosing does not mean discontinuation from the study. Remaining study 
procedures should be completed as indicated by the study protocol regardless of whether the 
participant is on active treatment. If a clinically significant finding is identified (including, but not 
limited to, changes from baseline) after enrollment, the investigator or qualified designee will 
determine if any change in study drug administration is needed. Any new, clinically relevant 
finding that is both unexpected and thought to be related to the drug will be reported as an SAE 
under Other Medically Important Event as described in Section 8.2.2. All AEs and SAEs will be 
reported and captured in the CRF. 
 
7 
STUDY PROCEDURES AND SCHEDULE 
7.1 STUDY PROCEDURES 
7.1.1 STUDY SPECIFIC PROCEDURES 
All procedures listed here are specific to the study and are not part of standard clinical care: 
• 
Review and sign informed consent 
• 
Eligibility criteria review 
• 
Biological specimen collection 
o Two 10 milliliter (mL) tube of blood (20 mL total) will be collected via 
venipuncture  
• 
Archival FFPE tissue submission (if historical CGP and/or Strata RNA profiling results 
are unavailable or as otherwise indicated within the cohort-specific criteria) 
• 
Biomarker confirmation (biomarker test results) 
• 
Data collection of any standard of care procedures conducted as part of regular clinical 
visits 
• 
Study drug dispensing 
• 
Study drug administration 
• 
CT/MRI scan of abdomen, chest, and pelvic area 
• 
Tumor assessments (RECIST 1.1 or iRECIST) 
• 
Drug administration and accountability 
• 
Evaluation and documentation of adverse events (AEs) or serious adverse events 
(SAEs) 
• 
Electrocardiograms (EKGs) and/or echocardiogram (Echo) are required for eligibility 
determination at screening. If not done as part of standard of care work-up or historical 
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EKG and/or Echo are not available, these tests should be performed as research 
procedures. 
• 
A serum pregnancy test is required if the pre-treatment urine pregnancy test is positive 
or inconclusive.  Pregnancy tests must be documented as negative within 3 days of 
study treatment. 
7.1.2 STANDARD OF CARE PROCEDURES  
All procedures listed here may be conducted as part of standard clinical care but are not 
required to be done for study purposes only (refer to Tables C and D for the Schedule of 
Activities). These SOC procedures are not billable to the study and should only be done if 
needed for clinical care.  
 
Regardless of whether the following are performed during a standard of care clinical visit, or in 
combination with study procedures, all relevant data collected must be entered into the EDC 
system. The data entry of both SOC procedures and study-specific procedures is a required 
study activity to meet study objectives and endpoints. 
• 
Demographics and disease/medical characteristics including: 
o Demographics 
o Disease history (date of first diagnosis, treatment history) 
o Current medical history (within the last 30 days) including medical illnesses and 
conditions, and surgical procedures not related to primary diagnosis. 
o  COVID-19 vaccination and disease history 
o Previous and concomitant medication within the last 30 days before screening 
• 
Complete or abbreviated physical examination 
o Information to be recorded may include results, abnormal findings, and clinical 
significance for various body systems examined. 
• 
Performance Status (ECOG) 
• 
Vital signs, including height, weight, blood pressure, heart rate, and respiration rate 
• 
Standard local laboratory assessments including hematology, serum chemistry (albumin, 
alkaline phosphatase, total bilirubin, bicarbonate, blood urea nitrogen (BUN), calcium, 
chloride, creatinine, glucose, lactate dehydrogenase (LDH), phosphorus, potassium, 
total protein, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and 
sodium) 
• 
Urine pregnancy test for females of childbearing potential within 3 days prior to 
treatment. 
 
7.2 STUDY SCHEDULE 
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7.2.1 SCHEDULE OF ACTIVITIES 
 
The schedules of activities (SOA) for both the tdMeta and µMeta cohorts are detailed in Table C 
and Table D. StrataPATH is designed to mimic real-world practice and will have a limited 
number of study-specific visits (Section 7.1). The visit schedules are comprised of a 
combination of study-specific visits and standard of care (SOC) visits. Participants will be 
followed for up to 3 years from the time of consent. 
 
SOC procedures listed in the SOA typically occur during standard clinical visits and are to be 
documented within the EDC system at the timepoints outlined in the SOA. 
 
 
 
 
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Table C: StrataPATH Schedule of Activities – tdMeta Cohorts 
 
Screening
Baseline
On Treatment
Post-Treatmentg
Study Procedures
Review and Sign Informed Consent Form
X
Eligibility Criteria Review (Main and Cohort-Specific)
X
X
Biomarker Confirmation
X
CT Scan or MRI of Abdomen, Chest, and Pelvic Area
Xa
Xb,c
RECIST 1.1 (or iRECIST) Assessment
X
Xb,c
Blood Draw: Whole Blood
X
Xb,c
FFPE Tissue Collection
Xd
Study Drug Administration
Xi
Xi
Study Drug Accountability
X
X
Xh
Study Drug Discontinuation
Xh
Standard of Care (SOC) Procedurese
Documentation of Biomarker Results
Xe
Demographics
Xe
Medical History
Xe,f
Xe
Xe
Cancer Diagnosis
Xe
Prior and Concomitant Medications
Xe,f
Xe
Xe
Physical Exam (Complete or Abbreviated)
Xe
Xe
Xe
ECOG Performance Status
Xe
Xe
Xe
Xe
Height, Weight, Vital Signs
Xe
Xe
Xe
Electrocardiogram (EKG)
Xj
Xe
Xe
Echocardiogram (Echo)
Xj
Hematology
Xe
Xe
Xe
Serum Chemistry
Xe
Xe
Xe
Urine Pregnancy Test, Serum Pregnancy Testk
Xe
Xe
Xe
Safety Evaluation
Adverse Events/Serious Adverse Events
X
X
X
aIf a scan was performed within 28 days of the baseline visit, these results should be submitted to the study.
bCollect every 8 weeks (± 2 weeks) during year 1 on treatment. After year 1 of treatment, collect every 12 weeks (± 2 
weeks). Collect upon disease progression.
cConfirmation of progression (e.g., confirmatory scan 4 weeks after initial progression assessment).
dOnly required if historical comprehensive genomic or Strata RNA profiling results are not available or otherwise indicated 
within the cohort-specific criteria. Site should collect and submit a leftover tumor tissue specimen to the Strata Lab for 
confirmatory testing with a central next generation sequencing test.
eThe specified SOC procedures should be conducted only if they are necessary for clinical care and should not be done for 
research purposes only. If any of these SOC activities are conducted at a regular clinic visit, the data obtained must be 
entered in the EDC for the study. 
fEnter information from medical records obtained up to 30 days prior to the screening visit.
gEvery 3 months for up to 3 years from the date of consent or until death, whichever comes first.
hStudy drug will be discontinued upon progression or per physician discretion. Study drug discontinuation and 
accountability activities will only be performed once during post-treatment.
iThe frequency of study drug dispensing and administration will be determined by the biomarker/study drug cohort in 
which the patient is enrolled.
jIf not SOC and historical data not available, can be research activity.
kOnly if urine test is positive or inconclusive; serum test can be research activity.
STUDY VISITS
(participation up to 3 years)
SCHEDULE OF ACTIVITIES
STR-004-001: StrataPATH 
tdMeta Cohorts
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Table D: StrataPATH Schedule of Activities – µMeta Cohorts  
 
Screening
Baseline
On Treatment
Post-Treatmente
Study Procedures
Review and Sign Informed Consent Form
X
Eligibility Criteria Review (Main and Cohort-Specific)
X
X
Biomarker Confirmation
X
Blood Draw: Whole Blood
X
Xb
FFPE Tissue Collection
Xa
Study Drug Administration
Xg
Xg
Study Drug Accountability
X
X
Xf
Study Drug Discontinuation
Xf
Standard of Care (SOC) Procedures 
Documentation of Biomarker Results
Xc
Demographics
Xc
Medical History
Xc,d
Xc
Xc
Cancer Diagnosis
Xc
Prior and Concomitant Medications
Xc,d
Xc
Xc
Physical Exam (Complete or Abbreviated)
Xc
Xc
Xc
ECOG Performance Status
Xc
Xc
Xc
Xc
Height, Weight, Vital Signs
Xc
Xc
Xc
Electrocardiogram (EKG)
Xh
Xc
Xc
Echocardiogram (Echo)
Xh
Hematology
Xc
Xc
Xc
Serum Chemistry
Xc
Xc
Xc
Urine Pregnancy Test, Serum Pregnancy Testi
Xc
Xc
Xc
Safety Evaluation
X
X
X
STUDY VISITS
(participation up to 3 years)
aOnly required if historical comprehensive genomic or Strata RNA profiling results are not available or otherwise indicated 
within the cohort-specific criteria. Site should collect and submit a leftover tumor tissue specimen to the Strata Lab for 
confirmatory testing with a central next generation sequencing test.
bCollected every 8 weeks (± 2 weeks) during year 1 on treatment. Collect every 12 weeks (± 2 weeks) after year 1 on 
treatment. Collect upon disease progression.
cThe specified SOC procedures should be conducted only if they are necessary for clinical care and should not be done for 
research purposes only. If any of these SOC activities are conducted at a regular clinic visit, the data obtained must be 
entered in the EDC for the study.
dEnter information from medical records obtained up to 30 days prior to the screening visit.
eEvery 3 months for up to 3 years from the date of consent or until death, whichever comes first.
fStudy drug will be discontinued upon progression or per physician discretion. Study drug discontinuation and 
accountability activities will only be performed once during the post-treatment phase.
gThe frequency of study drug dispensing and administration will be determined by the biomarker/study drug cohort in 
which the patient is enrolled.
hIf not SOC and historical data not availible, can be research activity.
iOnly if urine test is positive or inconclusive; serum test can be research activity.
SCHEDULE OF ACTIVITIES
µMeta Cohorts
STR-004-001 - StrataPATH 
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7.2.2 tdMETA COHORTS 
7.2.2.1 SCREENING 
• 
Obtain informed consent of potential participant verified by signature on written 
informed consent form 
• 
Review medical history, including biomarker status and cancer diagnosis, to 
determine eligibility based on inclusion/exclusion criteria (Sections 5.1-5.2) 
• 
Enter data from any standard of care procedures in the EDC 
• 
Submit biomarker confirmation form 
• 
If no historical Strata CGP or RNA profiling test results are available, submit a left-
over FFPE tumor specimen for confirmation by a central lab 
7.2.2.2 BASELINE 
• 
Verify eligibility per inclusion/exclusion criteria 
• 
Review of medications 
• 
Negative pregnancy test (urine or serum) 
 
• 
Obtain two 10 mL tubes of whole blood 
o Complete research blood collection form 
• 
Conduct CT scan or MRI of abdomen, chest, and pelvic area 
o If a scan was conducted within 28 days of the baseline visit, these results should 
be submitted; an additional scan is not required for the baseline visit. 
• 
Complete RECIST 1.1 (or iRECIST) assessment  
• 
Dispense study drug and review dosing instructions 
• 
Administer study drug and/or review administration instructions with participant 
• 
Perform drug accountability 
• 
Enter data from any standard of care procedures in the EDC, including ECOG status 
• 
Document any AEs or SAEs 
7.2.2.3 ON TREATMENT 
• 
Review of medications 
• 
Negative pregnancy test (urine or serum) 
• 
Obtain two 10 mL tubes of whole blood every 8 weeks during the first year of 
treatment and every 12 weeks thereafter and once upon disease progression 
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o Complete research blood collection form 
• 
Conduct CT scan or MRI of abdomen, chest, and pelvic area every 8 weeks during 
the first year of treatment and every 12 weeks thereafter 
o At progression, perform a confirmatory CT scan or MRI (e.g., 4 weeks after initial 
progression assessment) 
• 
Complete RECIST 1.1 (or iRECIST) assessment every 8 weeks during the first year 
of treatment and every 12 weeks thereafter 
o At progression, perform RECIST 1.1 (or iRECIST) assessment (e.g., 4 weeks 
after initial progression assessment) 
• 
Dispense study drug 
• 
Administer study drug and/or review administration instructions with participant 
• 
Perform drug accountability 
• 
Enter data from any standard of care procedures in the EDC, including ECOG status  
• 
Document any AEs or SAEs 
7.2.2.4 POST-TREATMENT 
Study drug will be discontinued upon disease progression or based on physician’s discretion as 
described in Section 5.5. Site staff should collect unused study drug and any empty packaging 
and perform drug accountability upon study drug discontinuation. Participants that discontinue 
drug will remain on study for 3 years from the date of informed consent for follow-up data entry 
purposes only. No additional study specific procedures will occur following discontinuation. 
Participants will continue to see their physician for SOC clinic visits. Site staff will be responsible 
for collecting and entering the information below in EDC from the participants SOC clinic visits 
every 3 months.  
• 
Medical history (specifically, disease recurrence and/or survival status) 
• 
Concomitant medications (specifically, anticancer therapies) 
• 
Standard of care procedures, including ECOG status 
7.2.3 µMETA COHORTS 
Note that µMeta cohorts will not have CT/MRI scans or RECIST 1.1 (or iRECIST) assessments 
performed. 
7.2.3.1 SCREENING 
• 
Obtain informed consent of potential participant verified by signature on written informed 
consent form 
• 
Review medical history, including biomarker status and cancer diagnosis, to determine 
eligibility based on inclusion/exclusion criteria (Sections 5.1-5.2) 
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• 
Enter data from any standard of care procedures in the EDC, including ECOG status 
• 
Submit biomarker confirmation form through the EDC 
• 
If no historical CGP test results are available, submit an FFPE tumor specimen for 
confirmation by a central lab. 
7.2.3.2 BASELINE 
• 
Verify eligibility per inclusion/exclusion criteria 
• 
Review of medications 
• 
Negative pregnancy test (urine or serum) 
 
• 
Obtain two 10 mL tubes of whole blood and complete research blood collection form 
• 
Dispense study drug and review dosing instructions 
• 
Administer study drug and/or review administration instructions with participant 
• 
Perform drug accountability 
• 
Enter data from any standard of care procedures in the EDC, including ECOG status 
• 
Document any AEs or SAEs 
7.2.3.3 ON TREATMENT 
• 
Review of medications 
• 
Negative pregnancy test (urine or serum) 
• 
Obtain two 10 mL tubes of whole blood and complete research blood collection form 
every 8 weeks during the first year of treatment and every 12 weeks thereafter and once 
upon disease progression 
o Complete research blood collection form 
• 
Dispense study drug 
• 
Administer study drug and/or review administration instructions with participant 
• 
Perform drug accountability 
• 
Enter data from any standard of care procedures in the EDC, including ECOG status  
• 
Document any AEs or SAEs 
7.2.3.4 POST-TREATMENT 
Study drug will be discontinued upon disease progression or based on physician’s discretion as 
described in Section 5.5. Site staff should collect unused study drug and any empty packaging 
and perform drug accountability upon study drug discontinuation. Participants that discontinue 
drug will remain on study for 3 years from the date of informed consent for follow-up data entry 
purposes only. No additional study specific procedures will occur following discontinuation. 
Participants will continue to see their physician for SOC clinic visits. Site staff will be responsible 
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for collecting and entering the information below in EDC from the participants SOC clinic visits 
every 3 months. 
• 
Medical history (specifically, disease recurrence and/or survival status) 
• 
Concomitant medications (specifically, anticancer therapies) 
• 
Standard of care procedures, including ECOG status 
 
7.3 EFFICACY ASSESSMENTS  
7.3.1 tdMETA COHORTS 
Study procedures and evaluations to assess efficacy are listed below.  
 
Response Assessment: 
Participants will undergo tumor assessments as designated in the Schedule of Activities (Table 
C, Section 7.2.1) until disease progression (regardless of whether or not the participant is still 
receiving study treatment) or until the participant discontinues the study drug or starts 
alternative anticancer treatment. At the investigator’s discretion, tumor assessments may be 
repeated at any time if progressive disease is suspected. 
 
Confirmation assessment of progressive disease must be obtained at least 4 weeks after the 
initial disease assessment indicating progressive disease. After confirmation of progressive 
disease, participants must complete the end of treatment visit and enter the post-treatment 
follow-up period. 
 
All active study participants who discontinue study drug for reasons other than disease 
progression (e.g., AEs) will continue tumor assessments until death, disease progression, 
initiation of another systemic anticancer therapy, lost to follow-up, withdrawal of consent, PI’s 
decision, or study termination, whichever occurs first. 
 
Measurable and evaluable lesions should be assessed and documented at baseline. Response 
assessments performed as standard of care prior to obtaining informed consent and within 28 
days prior to enrollment do not have to be repeated at screening. 
 
Baseline disease assessments will include a CT scan of the chest and abdomen/pelvis. CT 
scans of the neck and/or extremities should be performed as clinically indicated. Post-baseline 
disease assessments will include a CT scan of the chest and abdomen/pelvis for all 
participants. CT scans of the neck and/or extremities and brain MRIs should be repeated 
throughout the study if there is evidence of disease at screening or if clinically indicated. All 
scans should be performed in accordance with RECIST 1.1 and with contrast. If contrast is 
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contraindicated (i.e., in participants with known contrast dye allergy or impaired renal 
clearance), a chest CT without contrast and an abdomen/pelvis MRI without contrast may be 
performed.  
 
If a CT scan for a tumor assessment is performed in a positron emission tomography/CT 
scanner, the CT acquisition must be consistent with the standards for a full contrast diagnostic 
CT scan. 
 
Images will be collected and centrally stored to allow for retrospective review, if indicated. 
 
All measurable and evaluable lesions should be reassessed at each subsequent tumor 
evaluation. The same radiographic procedures used to assess disease sites at screening 
should be used for subsequent tumor assessments (e.g., same modality and contrast protocol).  
 
Response will be assessed by the Investigator using RECIST 1.1 (primary; see operations 
manual) and iRECIST (secondary; see operations manual). Assessments should be performed 
by the same evaluator, if possible, to ensure internal consistency across visits. Results must be 
reviewed by the investigator before dosing at the next cycle. 
7.3.2 µMETA COHORTS 
Post-SOC imaging or testing, investigators should denote disease-free status within the 
electronic health record (EHR). The physician note should also be entered into the EDC. 
Please review the study’s operations manual for specific instructions.  
 
8 
SAFETY ASSESSMENTS AND PROCEDURES 
8.1 SAFETY AND OTHER ASSESSMENTS 
Study procedures and evaluations to monitor safety and support the understanding of the study 
intervention’s safety, or that are done for other purposes (e.g., screening, eligibility, enrollment), 
are listed below. Most assessments should be completed as per standard of care monitoring 
and data will be extracted from the electronic health records and entered in the EDC.  
 
Study-Specific Procedure 
• 
Assessment of adverse events 
Standard of Care Evaluation – Data prescribed in CRF and extracted from electronic health 
records. 
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• 
Demographics and disease/medical characteristics including: 
o Participant demographics 
o Disease history (date of first diagnosis, treatment history) 
o Biomarker status (biomarker test results) 
o Medical history including documentation of prior and ongoing medical illnesses 
and conditions, and surgical procedures (those not related to primary diagnosis), 
previous diseases and concomitant diseases within the last 30 days before 
screening 
o Previous and concomitant medication 
• 
Complete or abbreviated physical examination including a review of all body systems. 
Information to be recorded may include height, weight, organ systems, motor or vision 
assessment. 
• 
Performance Status (ECOG). 
• 
Vital signs should be assessed including blood pressure, heart rate, body temperature, 
and respiration rate.  
• 
Standard local laboratory assessments, such as hematology, serum chemistry (albumin, 
alkaline phosphatase, total bilirubin, bicarbonate, BUN, calcium, chloride, creatinine, 
glucose, LDH, phosphorus, potassium, total protein, AST, ALT, and sodium). 
• 
Urine pregnancy test for females of child-bearing potential. 
• 
Electrocardiograms and Echocardiograms as indicated for the participant per standard of 
care guidelines. 
Please review the study’s operations manual for specific instructions.  
 
8.2 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.2.1 DEFINITION OF ADVERSE EVENTS (AE) 
Adverse event means any untoward medical occurrence associated with the use of an 
intervention in humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
8.2.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
An AE or suspected adverse drug reaction is considered serious if, in the view of either the 
investigator or sponsor, it results in any of the following outcomes:  
• 
Death,  
• 
Life-threatening adverse event,  
• 
Inpatient hospitalization or prolongation of existing hospitalization,  
• 
Persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions, or 
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• 
Congenital anomaly/birth defect.  
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgment, 
they may jeopardize the participant and may require medical or surgical intervention to prevent 
one of the outcomes listed in this definition. Examples of such medical events include allergic 
bronchospasm requiring intensive treatment in an emergency room or at home, blood 
dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of 
drug dependency or drug abuse. 
8.2.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.2.3.1 SEVERITY OF EVENT 
All AEs will be assessed by the study investigator using the National Cancer Institute (NCI) 
Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.  
8.2.3.2 RELATIONSHIP TO STUDY INTERVENTION 
All AEs must have their relationship to study intervention assessed by the investigator who 
examines and evaluates the participant based on temporal relationship and their clinical 
judgment. The degree of certainty about causality will be graded using the categories below. In 
a clinical trial, the study product must always be suspect.  
• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other 
possible contributing factors can be ruled out. The clinical event, including an abnormal 
laboratory test result, occurs in a plausible time relationship to study intervention 
administration and cannot be explained by concurrent disease or other drugs or 
chemicals. The response to withdrawal of the study intervention (dechallenge) should be 
clinically plausible. The event must be pharmacologically or phenomenologically 
definitive, with use of a satisfactory rechallenge procedure if necessary. 
• 
Probably Related – There is evidence to suggest a causal relationship, and the 
influence of other factors is unlikely. The clinical event, including an abnormal laboratory 
test result, occurs within a reasonable time after administration of the study intervention, 
is unlikely to be attributed to concurrent disease or other drugs or chemicals, and follows 
a clinically reasonable response on withdrawal (dechallenge). Rechallenge information is 
not required to fulfill this definition. 
• 
Possibly Related – There is some evidence to suggest a causal relationship (e.g., the 
event occurred within a reasonable time after administration of the trial medication). 
However, other factors may have contributed to the event (e.g., the participant’s clinical 
condition, other concomitant events). Although an AE may rate only as “possibly related” 
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soon after discovery, it can be flagged as requiring more information and later be 
upgraded to “probably related” or “definitely related”, as appropriate. 
• 
Unlikely to be Related – A clinical event, including an abnormal laboratory test result, 
whose temporal relationship to study intervention administration makes a causal 
relationship improbable (e.g., the event did not occur within a reasonable time after 
administration of the study intervention) and in which other drugs or chemicals or 
underlying disease provides plausible explanations (e.g., the participant’s clinical 
condition, other concomitant treatments). 
• 
Not Related – The AE is completely independent of study intervention administration, 
and/or evidence exists that the event is definitely related to another etiology. There must 
be an alternative, definitive etiology documented by the study investigator. 
8.2.3.3 EXPECTEDNESS  
The study physician will be responsible for determining whether an AE is expected or 
unexpected. An AE will be considered unexpected if the nature, severity, or frequency of the 
event is not consistent with the risk information described in the package insert for each 
interventional product. 
8.2.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND 
FOLLOW-UP 
The occurrence of an AE or SAE may come to the attention of study personnel during study 
visits and interviews of a study participant presenting for medical care, or upon review by a 
study monitor. 
 
All AEs, including local and systemic reactions not meeting the criteria for SAEs, will be 
captured on the appropriate CRF. Information to be collected includes event description, time of 
onset, investigator’s assessment of severity, relationship to study product (assessed only by 
those with the training and authority to make a diagnosis), and time of resolution/stabilization of 
the event. Regardless of relationship, all AEs occurring while on study must be documented and 
followed to adequate resolution. 
 
Any medical condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant’s condition 
deteriorates at any time during the study, it will be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of 
the event at each level of severity to be performed. AEs characterized as intermittent require 
documentation of onset and duration of each episode. 
 
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Study site will record all reportable events with start dates occurring any time after informed 
consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of 
study participation. At each study visit, the investigator will inquire about the occurrence of 
AE/SAEs since the last visit. Events will be followed for outcome information until resolution or 
stabilization. 
8.2.5 ADVERSE EVENT REPORTING  
The investigator is responsible for reporting the information to the study sponsor and local 
regulatory authorities, as required. 
8.2.6 SERIOUS ADVERSE EVENT REPORTING  
The investigator will immediately report any SAE to the sponsor, whether or not it is considered 
study intervention related, including those listed in the protocol or package insert. The report 
must include an assessment of whether there is a reasonable possibility that the study 
intervention caused the event. Study endpoints that are SAEs (e.g., all-cause mortality) must be 
reported in accordance with the protocol unless there is evidence suggesting a causal 
relationship between the study intervention and the event (e.g., death from anaphylaxis). In that 
case, the investigator must immediately report the event to the sponsor. 
 
All SAEs will be followed until satisfactory resolution or until the investigator deems the event to 
be chronic or the participant is stable. Other supporting documentation of the event may be 
requested by the study sponsor and should be provided as soon as possible. 
8.2.7 REPORTING EVENTS TO PARTICIPANTS  
Section not applicable 
8.2.8 EVENTS OF SPECIAL INTEREST  
All deaths that occur during the study must be reported as follows: 
• 
Death that is clearly the result of disease progression should be documented but not 
reported as an SAE. 
• 
Where death is not due (or not clearly due) to progression of the disease under study, 
the AE causing the death must be reported as an SAE within 24 hours of knowledge of 
the event.  
• 
Deaths with an unknown cause should always be reported as an SAE. 
8.2.9 REPORTING OF PREGNANCY  
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Female participants with the ability to get pregnant will be required to be on a double barrier 
birth control method for the duration of the trial in all cohorts. Male participants with female 
partners of child-bearing potential should be advised on birth control approach based on the 
study drug cohort.  
 
Participants who become pregnant during the study period should not receive any additional 
doses but will not be discontinued from the study to allow for tracking of event outcome. 
Participants will be asked the date of their last menstrual period in lieu of a pregnancy test at 
each visit. Pregnancy in a participant who has received study intervention is required to be 
reported within 24 hours of knowledge of the event to the sponsor. 
8.2.10 REPORTING REQUIREMENTS 
This study is investigational new drug (IND) exempt. The following criteria must be met in order 
for a clinical investigation to be considered IND-exempt:  
(i) The investigation is not intended to be reported to FDA as a well-controlled study in support 
of a new indication for use nor intended to be used to support any other significant change in 
the labeling for the drug;  
(ii) If the drug that is undergoing investigation is lawfully marketed as a prescription drug 
product, the investigation is not intended to support a significant change in the advertising for 
the product;  
(iii) The investigation does not involve a route of administration or dosage level or use in a 
patient population or other factor that significantly increases the risks (or decreases the 
acceptability of the risks) associated with the use of the drug product; 
(iv) The investigation is conducted in compliance with the requirements for institutional review 
set forth in part 56 and with the requirements for informed consent set forth in part 50; and  
(v) The investigation is conducted in compliance with the requirements of § 312.7. 
 
StrataPATH meets the above criteria. This trial will be conducted in compliance with the 
requirements for review by an IRB (21 CFR part 56) and with the requirements for informed 
consent (21 CFR part 50).  
 
8.3 UNANTICIPATED PROBLEMS 
8.3.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
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The Office for Human Research Protections (OHRP) considers unanticipated problems (UPs) 
involving risks to participants or others to include, in general, any incident, experience, or 
outcome that meets all the following criteria: 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures 
that are described in the protocol-related documents, such as the IRB approved 
research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied, and 
• 
Related or possibly related to participation in the research (“possibly related” means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research), and 
• 
Suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously known 
or recognized. 
8.3.2  UNANTICIPATED PROBLEM REPORTING  
The investigator will report unanticipated problems to the reviewing IRB and to the study 
sponsor. The UP report will include the following information: 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB 
project number. 
• 
A detailed description of the event, incident, experience, or outcome.  
• 
An explanation of the basis for determining that the event, incident, experience, or 
outcome represents an UP. 
• 
A description of any changes to the protocol or other corrective actions that have been 
taken or are proposed in response to the UP. 
To satisfy the requirement for prompt reporting, UPs will be reported using the following 
timeline:  
• 
UPs that are adverse drug reactions (ADRs) will be reported to the to the study sponsor 
within 24 hours of the investigator becoming aware of the event. The event must be 
ultimately reported to the IRB within 1 week from the time of identification of the event.  
• 
Any other UP will be reported to the study sponsor within 5 business days of the 
investigator becoming aware of the problem. The event must be ultimately reported to 
the IRB within 2 weeks from the time of identification of the event.  
 
9 
STATISTICAL CONSIDERATIONS  
9.1 SAMPLE SIZE DETERMINATION 
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The study design is similar to a basket trial with each basket molecularly defined. For both 
cohorts (tdMeta and µMeta), sample size calculations were completed under the following 
assumptions: 
• 
Each cohort will enroll unique participants. Although participants may qualify for 
enrollment in more than one cohort, they will be enrolled in only one biomarker cohort 
(Refer to Section 10.2 for definitions). 
• 
Each molecularly defined cohort will be evaluated independently. 
• 
tdMeta and µMeta cohorts will be evaluated independently. 
Sample size was determined using a two-stage design based on minimizing the risk of a false 
negative result. The binomial probability of observing an exact number of responses was used 
similar to that in a Simon’s two-stage design.19,20 The null hypothesis that the true response rate 
is 0.05 will be tested against a one-sided alternative. In the first stage, 12 patients will be 
accrued per cohort. If there are 1 or fewer responses in these 12 patients, the study will be 
stopped for that cohort. Response will be defined as partial response or complete response for 
tdMeta cohorts and <50% ctDNA mean VAF ratio for μMeta cohorts. Otherwise, 23 additional 
patients will be accrued for a total of 35. The null hypothesis will be rejected if 6 or more 
responses are observed in 35 patients. This design yields a type I error rate of 0.001 and a 
power of 88% when the true response rate is 0.30. 
 
9.2 POPULATIONS FOR ANALYSES 
The population for this study is defined separately by molecular cohort and disease severity 
(tdMeta and µMeta). The study includes participants diagnosed with both ctDNA positive 
recurrence, and those who are traditionally defined metastatic, relapsed, refractory, or advanced 
stage III or IV solid tumors that meet the entry criteria for one of the biomarker cohorts. In 
addition, subgroup analyses may be conducted to assess antitumor activity in cohorts of 
participants defined by the multiple molecular markers. 
 
The analysis populations are defined in Table E according to cohort and disease severity. 
 
Table E: Populations for Analyses 
Population 
Description 
As-treated Population 
All participants who receive at least 1 dose of assigned therapy 
Intent-to-treat (ITT) 
Population  
All participants who provide written informed consent and are 
assigned therapy 
Modified ITT (mITT) 
Population 
All participants belonging to the ITT Population who receive at least 
1 dose of assigned therapy and 1 post-baseline scan 
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9.3 STATISTICAL ANALYSES 
9.3.1 GENERAL APPROACH 
This study will use an adaptive approach, with on-treatment data guiding trial adaptation and 
success or futility of each cohort. All statistical analyses will be pre-specified and finalized for 
each cohort prior to database lock. The statistical analysis plan (SAP) will describe the study 
populations to be included in the analyses and the procedures for accounting for missing, 
unused, and spurious data. High-level methods are described here. 
9.3.2 EFFICACY ANALYSES 
Efficacy analyses for ORR and DoR are based on the responses from Investigator-recorded 
measurements and assessments for target, nontarget, and new lesions according to RECIST 
1.1.21    
• 
ORR is defined as the percentage of participants with a best overall response of 
complete response (CR) or partial response (PR). 
• 
DoR is defined as the time from first documentation of disease response (CR or PR) 
until first documentation of progressive disease. 
Efficacy analyses for ctDNA response rate will be based on the proportion of participants 
considered responders compared to non-responder participants. Responders are defined as 
any participant with <50% ratio of mean VAF. 
 
ORR and ctDNA response rate will be estimated by the proportion of participants with objective 
response and ctDNA response respectively and their 95% confidence intervals will be estimated 
using the exact binomial method. Other time-to-event efficacy analyses including TTD, TTNT, 
DFS and OS will be summarized using the Kaplan-Meier method with the appropriate time-
defined cut-offs.  
Additional supportive analyses of efficacy endpoints may be conducted using iRECIST.22 
9.3.3 SAFETY ANALYSES 
 
The safety analysis will be based on the as-treated population. The incidence of ADR/ADEs and 
changes in baseline in vital signs, clinical laboratory parameters, physical examination findings, 
ECOG performance status, will be analyzed as data are available.  
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9.3.4 BIOMARKER ANALYSES 
If relevant data are available, relationships between biomarkers, biomarker changes and clinical 
outcomes may be explored.  
9.3.5 BASELINE DESCRIPTIVE STATISTICS 
Descriptive statistics will be used to summarize the analysis dataset based on all available 
clinical and biomarker data. For available quantitative measures such as age or biomarker 
expression values, the mean, median, standard deviation, minimum and maximum will be 
tabulated.  
 
For the quantitative measures, histograms and/or side-by-side boxplots will be presented and 
used to evaluate the underlying form of the distribution as well as the presence of any extreme 
values. It is important to ensure that the analysis is robust to identify a small number of outlying, 
extreme values or skewed data distributions. For expression data, log transformations are 
commonly used to create more symmetric data out of distributions that are skewed right. 
Presentation of histograms before and after transformations are useful to gauge the 
appropriateness of the transformation. 
9.3.6  PLANNED INTERIM ANALYSES  
For each cohort, 12 participants will be enrolled initially. If there is one response or no 
responses in these 12 participants as defined by CR or PR (for tdMeta) and ctDNA response 
(for µMeta), the study will be stopped in that cohort. A minimum rwRR/ctDNA response of 10% 
and risk-benefit profile that the sponsor deems promising will be required before an additional 
23 participants will be accrued for a total of 35 participants. 
9.3.7  LIMITATIONS OF ANALYSES 
 
The enrolled participants will be assigned to study cohorts based on molecular group status with 
hypothesized anti-tumor benefit. Consequently, any exploratory analyses for additional 
biomarker associations will be based on a potentially biased subset of the overall population. 
Statistical methodology will consider this potential bias. 
 
10 QUALITY ASSURANCE AND QUALITY CONTROL 
10.1.1 CLINICAL MONITORING 
Clinical site monitoring is conducted to ensure that the rights and well-being of participants are 
protected, that the reported trial data are accurate, complete, and verifiable, and that the 
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conduct of the trial is in compliance with the currently approved protocol/amendment(s), with 
ICH/GCP, and with applicable regulatory requirement(s).  
• 
Monitoring for this study will be performed by the study sponsor or designee.  
• 
A combination of on-site and remote monitoring will be used for this study. Targeted/risk-
based monitoring will be used to assess safety and key variables and verify endpoints. 
• 
Details of clinical site monitoring are documented in a Clinical Monitoring Plan (CMP). 
The CMP describes in detail who will conduct the monitoring, at what frequency 
monitoring will be done, at what level of detail monitoring will be performed, and the 
distribution of monitoring reports. 
• 
Independent audits may be conducted by Strata Oncology to ensure monitoring 
practices are performed consistently across all participating sites and that monitors are 
following the CMP. 
10.1.2 QUALITY ASSURANCE AND QUALITY CONTROL 
Each clinical site will perform internal quality management of study conduct, data and biological 
specimen collection, documentation, and completion. The investigational site will provide direct 
access to all trial related sites, source data/documents, and reports for the purpose of 
monitoring and auditing by the sponsor, and inspection by local and regulatory authorities. 
Quality control (QC) procedures will be implemented beginning with the data entry system and 
data QC checks that will be run on the database will be generated. Any missing data or data 
anomalies will be communicated to the site(s) for clarification/resolution. 
 
Following written Standard Operating Procedures (SOPs), the monitors will verify that the 
clinical trial is conducted, data are generated, and biological specimens are collected, 
documented (recorded), and reported in compliance with the protocol, ICH/GCP, and applicable 
regulatory requirements. 
 
11 ETHICS/PROTECTION OF HUMAN PARTICIPANTS 
11.1 INFORMED CONSENT PROCESS 
Prior to the beginning of the trial, the investigator will ensure the IRB’s written approval for the 
protocol and written ICF(s) as well as any other written information to be provided to the 
participants. The investigator must comply with applicable regulatory requirements (e.g., 45 
CFR Part 46, 21 CFR Part 50, 21 CFR Part 56) and must adhere to ICH GCP. 
 
The investigator is responsible for obtaining written informed consent from each participant 
enrolled in the trial. The investigator or designee must explain the study objectives, methods, 
and potential benefits and potential risks of study participation. Participants will also be informed 
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by the investigator or designee that they may withdraw from the study at any time for any 
reason. Original, signed consent forms will be maintained at the site and will be made available 
for inspection, as needed.  
11.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS 
PROVIDED TO PARTICIPANTS 
The ICF describes in detail the study intervention, study procedures, risks, and benefits to study 
participation as well as a statement informing the participant of their right to withdraw from the 
study at any time for any reason. Written informed consent is required prior to starting 
intervention/administering study intervention.  
11.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
Informed consent is a process that is initiated prior to an individual agreeing to participate in the 
study and continues throughout study participation. Consent forms will be IRB approved and the 
participant will be asked to read and review the document. The investigator will explain the 
research study to the participant and answer any questions that may arise. A verbal explanation 
will be provided in terms suited to the participant’s comprehension of the purposes, procedures, 
and potential risks of the study and of their rights as research participants. A translated version 
of the ICF will be provided in the participant’s primary language, as applicable. Participants will 
have the opportunity to carefully review the written consent form and ask questions prior to 
signing. The participants should have the opportunity to discuss the study with their family or 
surrogates or think about it prior to agreeing to participate. The participant will sign the ICF prior 
to any procedures being done specifically for the study. Participants must be informed that 
participation is voluntary and that they may withdraw from the study at any time, without 
prejudice. A copy of ICF will be given to the participants for their records.  
 
The informed consent process will be conducted and documented in the source document 
(including the date of consent), and the form signed, before the participant undergoes any 
study-specific procedures. The rights and welfare of the participants will be protected by 
emphasizing to them that the quality of their medical care will not be adversely affected if they 
decline to participate in this study. 
 
11.2 STUDY DISCONTINUATION AND CLOSURE 
The study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause. Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party to all study participants, 
investigators, funding agency, sponsor, and regulatory authorities, as applicable. If the study is 
prematurely terminated or suspended, the PI will promptly inform study participants, the IRB, 
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and sponsor and will provide the reason(s) for the termination or suspension. Study participants 
will be contacted, as applicable, and be informed of changes to study visit schedule. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping   
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
The study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the sponsor, IRB and/or FDA and/or applicable regulatory bodies. 
 
11.3 CONFIDENTIALITY AND PRIVACY  
Participant confidentiality and privacy is strictly maintained by the investigator, their staff, the 
sponsor and affiliated institutions involved in the conduct of the trial. These entities are 
responsible for ensuring participant identity is protected from unauthorized parties. This 
confidentiality is extended to cover testing of biological samples and genetic tests in addition to 
the clinical information relating to participants. The participants will be informed that 
representatives of the sponsor, IRB/independent ethics committee (IEC), or regulatory 
authorities may inspect their medical records to verify the information collected, and that all 
personal information made available for inspection will be handled in accordance with local data 
protection laws. The study protocol, documentation, data, and all other information generated 
will be held in strict confidence. No information concerning the study, or the data will be 
released to any unauthorized third party without prior written approval of the sponsor. All 
research activities will be conducted in as private a setting as possible. 
 
The study monitor, other authorized representatives of the sponsor, representatives of the IRB, 
regulatory agencies or pharmaceutical company supplying study product may inspect all 
documents and records required to be maintained by the investigator, including but not limited 
to, medical records (office, clinic, or hospital) and pharmacy records for the participants in this 
study. The clinical study site will permit access to such records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal 
use during the study. At the end of the study, all records will continue to be kept in a secure 
location for as long a period as dictated by the reviewing IRB, Institutional policies, or sponsor 
requirements. 
 
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Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored with the study sponsor or designee. This will not 
include the participant’s contact or identifying information. Rather, individual participants and 
their research data will be identified by a unique participant identification number. The study 
data entry and study management systems used by clinical sites and by study sponsor research 
staff will be secured and password protected. At the end of the study, all study databases will be 
de-identified and archived by the study sponsor or designee. 
 
11.4 FUTURE USE OF STORED SPECIMENS AND DATA  
Data collected for this study will be analyzed and stored at study sponsor or designee. After the 
study is completed, the de-identified, archived data will be stored at study sponsor or designee 
for potential use by other researchers including those outside of the study. De-identified data 
may be shared with third parties (including companies with which the sponsor has partnered for 
this study) or used by Strata Oncology for non-research purposes. 
 
With the participant’s consent and as approved by local IRBs, de-identified biological samples 
will be stored at the study sponsor’s designated location. These samples could be used for 
other research, such as into the causes of cancer, its complications and other conditions for 
which individuals with cancer are at increased risk, and to improve treatment, including new test 
development. Study sponsor will have a code-link that will allow linking the biological specimens 
with the phenotypic data from each participant, maintaining the blinding of the identity of the 
participant. 
 
During the conduct of the study, a participant can choose to withdraw consent to have biological 
specimens stored for future research. However, after the study is completed, a participant may 
not be able to withdraw consent to have their samples stored. 
 
When the study is completed, access to study data and/or samples will be provided through the 
study sponsor.  
 
11.5 KEY ROLES AND STUDY GOVERNANCE 
Please refer to the operations manual for the list of study team roles and responsibilities of 
those involved in the conduct, management, or oversight of the trial. 
 
11.6 SAFETY OVERSIGHT 
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Strata Oncology / STR-004-001 
 
Amendment 2 (13-Mar-2023) 
The information contained in this protocol and all other information relevant to this study are confidential and 
proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 53 of 56 
 
Participant safety will be monitored by a Data and Safety Monitoring Board (DSMB) for this 
study. The DSMB is independent from the study sponsor and the DSMB’s membership includes 
clinical oncology experts, a biostatistician, and investigators with expertise in clinical trial 
conduct and methodology. The DSMB will receive accrual reports every 3 months and meet 
every 6 months to review study participant demographic representation, baseline 
characteristics, protocol compliance, study safety, and any updates to the study protocol. The 
DSMB will also meet ad hoc as needed. 
 
12 DATA HANDLING AND RECORD KEEPING 
12.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of the clinical trial staff at the site under the supervision of 
the investigator. The investigator is responsible for ensuring the accuracy, completeness, 
attributability, legibility, originality and timeliness of the data reported. All source documents 
should be completed in a neat, legible manner to ensure accurate interpretation of data.  
 
Clinical data (including AE/SAEs, concomitant medications, and expected adverse reactions 
data) and clinical laboratory data will be entered in a 21 CFR Part 11-compliant data capture 
system provided by the study sponsor. The data system includes password protection and 
internal quality checks, such as automatic range checks, to identify data that appear 
inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the source 
documents. 
 
12.2 STUDY RECORDS RETENTION  
Study documents should be retained until at least 2 years have elapsed since the formal 
discontinuation of clinical development of the study intervention. These documents should be 
retained for a longer period, however, if required by local regulations. No records will be 
destroyed without the written consent of the sponsor, if applicable. It is the responsibility of the 
sponsor to inform the investigator when these documents no longer need to be retained. 
 
12.3 PROTOCOL DEVIATIONS  
A protocol deviation is any noncompliance with the clinical trial protocol, ICH/GCP, or operations 
manual requirements. The noncompliance may be either on the part of the participant, the 
investigator, or the study site staff. As a result of deviations, corrective actions are to be 
developed by the site and implemented promptly.  
 
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Amendment 2 (13-Mar-2023) 
The information contained in this protocol and all other information relevant to this study are confidential and 
proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 54 of 56 
 
These practices are consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, section 5.1.1  
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
It is the responsibility of the investigator to use continuous vigilance to identify and report 
deviations. All deviations must be addressed in study source documents and reported to Strata 
Oncology monitor and/or Site Management Associate. Protocol deviations must be sent to the 
reviewing IRB per their policies. The investigator/sponsor is responsible for knowing and 
adhering to the reviewing IRB requirements. 
 
12.4 PUBLICATION AND DATA SHARING POLICY 
 
This trial is registered at ClinicalTrials.gov (NCT05097599), and results information from this 
trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish 
results in peer-reviewed journals.  
 
13 CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence, is critical. Therefore, any 
actual conflict of interest of persons who have a role in the design, conduct, analysis, 
publication, or any aspect of this trial will be disclosed and managed. Furthermore, persons who 
have a perceived conflict of interest will be required to have such situations managed in a way 
that is appropriate to their participation in the design and conduct of this trial.  
 
14 REFERENCES  
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https://cancerstatisticscenter.cancer.org/#/. 
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Miller, K.D., Nogueira, L., Mariotto, A.B., Rowland, J.H., Yabroff, K.R., Alfano, C.M., 
Jemal, A., Kramer, J.L., and Siegel, R.L. (2019). Cancer treatment and survivorship 
statistics, 2019. CA Cancer J Clin 69, 363-385. 10.3322/caac.21565. 
3. 
US Food and Drug Administration (2017). FDA grants accelerated approval to 
pembrolizumab for first tissue/site agnostic indication. 
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Le, D.T., Durham, J.N., Smith, K.N., Wang, H., Bartlett, B.R., Aulakh, L.K., Lu, S., 
Kemberling, H., Wilt, C., Luber, B.S., et al. (2017). Mismatch repair deficiency predicts 
response of solid tumors to PD-1 blockade. Science 357, 409-413. 
10.1126/science.aan6733. 
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Amendment 2 (13-Mar-2023) 
The information contained in this protocol and all other information relevant to this study are confidential and 
proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 55 of 56 
 
5. 
US Food and Drug Administration (2018). FDA approves larotrectinib for solid tumors 
with NTRK gene fusions. 
6. 
Wu, Y.L., Tsuboi, M., He, J., John, T., Grohe, C., Majem, M., Goldman, J.W., Laktionov, 
K., Kim, S.W., Kato, T., et al. (2020). Osimertinib in Resected EGFR-Mutated Non-
Small-Cell Lung Cancer. N Engl J Med 383, 1711-1723. 10.1056/NEJMoa2027071. 
7. 
Ramalingam, S.S., Yang, J.C., Lee, C.K., Kurata, T., Kim, D.W., John, T., Nogami, N., 
Ohe, Y., Mann, H., Rukazenkov, Y., et al. (2018). Osimertinib As First-Line Treatment of 
EGFR Mutation-Positive Advanced Non-Small-Cell Lung Cancer. J Clin Oncol 36, 841-
849. 10.1200/JCO.2017.74.7576. 
8. 
Garon, E.B., Rizvi, N.A., Hui, R., Leighl, N., Balmanoukian, A.S., Eder, J.P., Patnaik, A., 
Aggarwal, C., Gubens, M., Horn, L., et al. (2015). Pembrolizumab for the treatment of 
non-small-cell lung cancer. N Engl J Med 372, 2018-2028. 10.1056/NEJMoa1501824. 
9. 
Eggermont, A.M.M., Blank, C.U., Mandala, M., Long, G.V., Atkinson, V., Dalle, S., 
Haydon, A., Lichinitser, M., Khattak, A., Carlino, M.S., et al. (2018). Adjuvant 
Pembrolizumab versus Placebo in Resected Stage III Melanoma. N Engl J Med 378, 
1789-1801. 10.1056/NEJMoa1802357. 
10. 
MSD (2021). Merck’s KEYTRUDA® (pembrolizumab) Demonstrated Superior Disease-
Free Survival (DFS) Compared With Placebo as Adjuvant Therapy in Patients With 
Renal Cell Carcinoma (RCC) Following Surgery. Press Release. 
11. 
US Food and Drug Administration (2018). Clinical Trial Endpoints for the Approval of 
Cancer Drugs and Biologics Guidance for Industry. 
12. 
Temple, R. (1995). A regualtory authority's opinion about surrogate endpoints. In Clinical 
Measurement in Drug Evaluation, W.T. Nimmo, ed. (J.Wiley). 
13. 
Khozin, S., Miksad, R.A., Adami, J., Boyd, M., Brown, N.R., Gossai, A., Kaganman, I., 
Kuk, D., Rockland, J.M., Pazdur, R., et al. (2019). Real-world progression, treatment, 
and survival outcomes during rapid adoption of immunotherapy for advanced non-small 
cell lung cancer. Cancer. 10.1002/cncr.32383. 
14. 
Blumenthal, G.M., Gong, Y., Kehl, K., Mishra-Kalyani, P., Goldberg, K.B., Khozin, S., 
Kluetz, P.G., Oxnard, G.R., and Pazdur, R. (2019). Analysis of time-to-treatment 
discontinuation of targeted therapy, immunotherapy, and chemotherapy in clinical trials 
of patients with non-small-cell lung cancer. Ann Oncol 30, 830-838. 
10.1093/annonc/mdz060. 
15. 
Prentice, R.L. (1989). Surrogate endpoints in clinical trials: definition and operational 
criteria. Stat Med 8, 431-440. 10.1002/sim.4780080407. 
16. 
Fleming, T.R., and Powers, J.H. (2012). Biomarkers and surrogate endpoints in clinical 
trials. Stat Med 31, 2973-2984. 10.1002/sim.5403. 
17. 
Thompson, J.C., Carpenter, E.L., Silva, B.A., Rosenstein, J., Chien, A.L., Quinn, K., 
Espenschied, C.R., Mak, A., Kiedrowski, L.A., Lefterova, M., et al. (2021). Serial 
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Amendment 2 (13-Mar-2023) 
The information contained in this protocol and all other information relevant to this study are confidential and 
proprietary information of Strata Oncology Inc., except as may be required by federal, state or local laws or 
regulation, and may not be disclosed to others without prior written permission of Strata. 
Page 56 of 56 
 
Monitoring of Circulating Tumor DNA by Next-Generation Gene Sequencing as a 
Biomarker of Response and Survival in Patients With Advanced NSCLC Receiving 
Pembrolizumab-Based Therapy. JCO Precision Oncology, 510-524. 
10.1200/po.20.00321. 
18. 
Zhang, Q., Luo, J., Wu, S., Si, H., Gao, C., Xu, W., Abdullah, S.E., Higgs, B.W., Dennis, 
P.A., van der Heijden, M.S., et al. (2020). Prognostic and Predictive Impact of Circulating 
Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint 
Blockade. Cancer Discov 10, 1842-1853. 10.1158/2159-8290.CD-20-0047. 
19. 
Jung, S.H., Lee, T., Kim, K., and George, S.L. (2004). Admissible two-stage designs for 
phase II cancer clinical trials. Stat Med 23, 561-569. 10.1002/sim.1600. 
20. 
Simon, R. (1989). Optimal two-stage designs for phase II clinical trials. Control Clin 
Trials 10, 1-10. 10.1016/0197-2456(89)90015-9. 
21. 
Eisenhauer, E.A., Therasse, P., Bogaerts, J., Schwartz, L.H., Sargent, D., Ford, R., 
Dancey, J., Arbuck, S., Gwyther, S., Mooney, M., et al. (2009). New response evaluation 
criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45, 228-
247. 10.1016/j.ejca.2008.10.026. 
22. 
Seymour, L., Bogaerts, J., Perrone, A., Ford, R., Schwartz, L.H., Mandrekar, S., Lin, 
N.U., Litiere, S., Dancey, J., Chen, A., et al. (2017). iRECIST: guidelines for response 
criteria for use in trials testing immunotherapeutics. Lancet Oncol 18, e143-e152. 
10.1016/S1470-2045(17)30074-8. 
 
COHORT APPENDICES 
See attached. 
 
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STR-004-001-PR (DOC-1513) Ver. 4
Approved By:
(CO-812) STRATA CHANGE ORDER
Description
Change Order 18-MAY-2023
Justification
Updating document description in Greenlight Guru to remove the number for the amendment.
Assigned To:
Initiated By:
Priority:
Impact:
Barb Holt
Barb Holt
Low
Minor
Version History:
Author
Effective Date
CO#
Ver.
Status
Barb Holt
May 18, 2023 10:36 AM EDT
CO-812
4
Published
Kat Corbitt
May 18, 2023 10:18 AM EDT
CO-782
3
Superseded
Ida Cao
August 20, 2021 12:35 PM EDT
CO-440
2
Superseded
Ida Cao
August 17, 2021 9:36 AM EDT
CO-428
1
Superseded
Ida Cao
May 4, 2021 12:04 PM EDT
CO-374
0
Superseded
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