Clinical trial NCT04632992: A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
Official title: MyTACTIC: An Open-Label Phase II Study Evaluating Targeted Therapies in Patients Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Unresectable or Metastatic Solid Malignancy
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase II, multicenter, non-randomized, open-label, multi-arm study designed to evaluate the safety and efficacy of targeted therapies as single agents or in rational, specified combinations in participants with advanced unresectable or metastatic solid tumors determined to harbor specific biomarkers.

Patients will be enrolled based on local testing performed at a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited diagnostic laboratory. The multi-arm structure of the MyTACTIC study allows patients with solid tumors to be treated with a drug or drug regimen tailored to their biomarker identified at screening.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic solid malignancy
* Positive biomarker results from a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited diagnostic laboratory and availability of a full report of the testing results. This may be from a tissue or blood sample.
* Evaluable or measurable disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Life expectancy ≥8 weeks
* Adequate hematologic and end-organ function, as defined in the protocol, obtained within 14 days prior to initiation of study treatment
* Agrees to take measures to prevent pregnancy in the patient or partner
* In addition to the general inclusion criteria above, there are treatment-specific inclusion criteria that apply for each respective treatment arm (as detailed in the protocol)

Exclusion Criteria:

* Current participation or enrollment in another therapeutic clinical trial
* Symptomatic or actively progressing CNS metastases (asymptomatic patients with treated or untreated CNS metastases may be eligible, provided all protocol-defined criteria are met)
* History of leptomeningeal disease, unless noted otherwise for a specific treatment arm of the study
* Wide field radiotherapy within 14 days prior to start of study treatment
* Stereotactic radiosurgery within 7 days prior to start of study treatment
* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infections, or any active infection that, in the opinion of the investigator, could impact patient safety
* Receipt of any anticancer drug/biologic or investigational treatment 21 days prior to Cycle 1, Day 1 except hormone therapy, which can be given up to 7 days prior to Cycle 1, Day 1 (androgen blockage may be continued for male patients with prostate cancer)
* Known human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infection with status outside of study-allowed criteria
* History of or concurrent serious medical condition or abnormality in clinical laboratory tests that precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study
* History of malignancy other than disease under study within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
* Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
* Major surgical procedure, other than for diagnosis, or significant traumatic injury within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
* Pregnant or breastfeeding, or intending to become pregnant during the study
* In addition to the general exclusion criteria above, there are treatment-specific exclusion criteria that apply for each respective treatment arm (as detailed in the protocol)

Primary outcomes:
measure: Confirmed Objective Response Rate (ORR) Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria for Primary Central Nervous System (CNS) Tumors
timeFrame: Up to 32 months
Secondary outcomes:
measure: Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
timeFrame: Time from start of treatment to the first occurrence of disease progression or death from any cause (Up to 32 months)
measure: Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
timeFrame: Time from the date of the first confirmed CR/PR to PD or death from any cause (Up to 32 months)
measure: PFS Rate at Month 3, 6, 9, and 12 as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
timeFrame: At Months 3, 6, 9 and 12
measure: Percentage of Participants With Disease Control, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
timeFrame: Up to 32 months
measure: Number of Participants With at Least One Adverse Event (AE) and Severity of AEs Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
timeFrame: From initiation of study drug until 28 days after the final dose of study drugs other than atezolizumab and until 90 days after the final dose of atezolizumab (Up to 32 months)
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology
state: Alaska
city: Oro Valley
country: United States
facility: Arizona Clinical Research Ctr
state: Arizona
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Encinitas
country: United States
facility: California Cancer Associates for Research and Excellence - Encinitas
state: California
city: Los Angeles
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care - Monterey
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente - San Francisco Medical Center
state: California
city: Santa Monica
country: United States
facility: Sarcoma Oncology Center
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Ctr
state: California
city: Ventura
country: United States
facility: Ventura County Hematology Oncology Specialists
state: California
city: Norwich
country: United States
facility: Eastern CT Hematology and Oncology Associates
state: Connecticut
city: Fort Myers
country: United States
facility: SCRI Florida Cancer Specialists South
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - NORTH - SCRI - PPDS
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialists - PAN - SCRI - PPDS
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - EAST - SCRI - PPDS
state: Florida
city: Boise
country: United States
facility: St Luke?s Cancer Institute
state: Idaho
city: Baton Rouge
country: United States
facility: Hematology and Oncology Clinic
state: Louisiana
city: Baltimore
country: United States
facility: Saint Agnes Hospital - Baltimore - Hunt - PPDS
state: Maryland
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Billings
country: United States
facility: Frontier Cancer Center and Blood Institute
state: Montana
city: Lincoln
country: United States
facility: Southeast Nebraska Cancer Center
state: Nebraska
city: Brick
country: United States
facility: New Jersey Hematology Oncology Associates LLC
state: New Jersey
city: East Brunswick
country: United States
facility: Astera Cancer Care East Brunswick
state: New Jersey
city: Bronx
country: United States
facility: Eastchester Center for Cancer Care
state: New York
city: Bronx
country: United States
facility: New York Cancer & Blood Specialists
state: New York
city: New York
country: United States
facility: Central Park Hematology and Oncology
state: New York
city: Asheville
country: United States
facility: Messino Cancer Centers
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Canton
country: United States
facility: Tri County Hematologyoncology
state: Ohio
city: Columbus
country: United States
facility: SCRI Mark H. Zangmeister Center
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente Center For Health Research
state: Oregon
city: Chattanooga
country: United States
facility: Sarah Cannon Research Institute / Tennessee Oncology
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic, PC dba West Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders - PPDS
state: Texas
city: San Antonio
country: United States
facility: Mays Cancer Center at UT Health San Antonio MD Anderson Cancer
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University - Massey Cancer Center
state: Virginia
city: Federal Way
country: United States
facility: Northwest Medical Specialties B
state: Washington
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: