Clinical trial NCT05487235: A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Official title: A Phase Ib, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Metastatic Solid Tumors
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-04
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of GDC-1971 when administered in combination with atezolizumab in participants with locally advanced or metastatic solid tumors.

The study will have 2 stages- dose finding stage and expansion stage. In expansion stage participants with non-small cell lung cancer programmed death ligand -1 high (NSCLC PD L-1 high), NSCLC PD L-1 low, head and neck squamous cell carcinoma (HNSCC) PD L-1 positive, BRAF wild type (BRAF WT) melanoma and any locally advanced or metastatic solid tumors will be enrolled.


Eligibility criteria: Inclusion Criteria:

* Has Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1
* Has Life expectancy \>= 12 weeks
* Adequate organ function
* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

Inclusion Criteria for Dose-Finding Stage:

* Histologically confirmed locally advanced or metastatic solid tumor that has progressed after at least one available standard therapy or for which approved standard therapy has proven to be ineffective or intolerable

Inclusion Criteria for Expansion Stage: NSCLC Cohort

* Histologically confirmed locally advanced or metastatic NSCLC
* Absence of epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK)
* PD- L1 positive
* No prior systemic therapy for locally advanced or metastatic NSCLC

Inclusion Criteria for Expansion Stage: HNSCC Cohort

* Histologically confirmed recurrent, or metastatic HNSCC
* PD-L1 positive
* No prior systemic therapy for recurrent or metastatic HNSCC

Inclusion Criteria for Expansion Stage: BRAF WT melanoma Cohort

* Histologically confirmed locally advanced or metastatic or unresectable locally advanced cutaneous BRAF WT melanoma or melanomas of unknown primary that are non-mucosal and non -uveal that has progressed on or after treatment that included anti PD1 or anti PD-L1 therapy

Inclusion Criteria for Expansion Stage: Other Advanced or Metastatic Solid Tumors Cohort

* Histologically confirmed locally advanced or metastatic solid tumor that has progressed after at least one available standard therapy or for which approved standard therapy has proven to be ineffective or intolerable, standard therapy is considered inappropriate, or an investigational agent is a recognized standard of care

Exclusion Criteria:

* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
* Has leptomeningeal disease or carcinomatous meningitis
* Has uncontrolled hypertension
* Has left ventricular ejection fraction \< institutional lower limit of normal or \< 50%
* Has clinically significant history of liver disease including viral or other hepatitis, current alcohol abuse, or cirrhosis
* Has an active or history of autoimmune disease or immune deficiency including myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or multiple sclerosis. Participants with a history of autoimmune- related hypothyroidism on thyroid replacement hormone or with controlled Type I diabetes mellitus on a stable dose of an insulin regimen are eligible for this study

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to approximately 2.5 years
measure: Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)
measure: Percentage of Participants With Clinically Significant Change from Baseline in Clinical Laboratory Test Results
timeFrame: Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)
measure: Percentage of Participants With Clinically Significant Change From Baseline in RR and QT Intervals as Measured by Electrocardiogram (ECG)
timeFrame: Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)
measure: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
timeFrame: From Day 1 to Day 21 of Cycle 1 of the dose finding stage
measure: Plasma Concentration of GDC-1971
timeFrame: Up to approximately 2.5 years
Secondary outcomes:
measure: Area Under the Concentration-Time Curve From Time 0 to 96 hours (AUC0-96 hr) Following GDC-1971 Capsule or Tablet Administration
timeFrame: Up to approximately 2.5 years
measure: AUC From Time 0 to Infinity (AUCinf) Following GDC-1971 Capsule or Tablet Administration
timeFrame: Up to approximately 2.5 years
measure: Cmax of GDC-1971 Following Capsule or Tablet Administration
timeFrame: Up to approximately 2.5 years
measure: AUC 0-96 hr Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions
timeFrame: Up to approximately 2.5 years
measure: AUC inf Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions
timeFrame: Up to approximately 2.5 years
measure: Cmax of GDC-1971 Following Tablet Administration Under Fasted and Fed Conditions
timeFrame: Up to approximately 2.5 years
measure: AUC 0-24 hr at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole
timeFrame: Up to approximately 2.5 years
measure: Cmax at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole
timeFrame: Up to approximately 2.5 years
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 2.5 years
measure: Duration of Response (DOR)
timeFrame: Up to approximately 2.5 years
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 2.5 years
measure: PFS Rate
timeFrame: Month 6
measure: Overall Survival (OS) Rate
timeFrame: Months 6 and 12
Other outcomes:
Locations:
city: Cordoba
country: Argentina
facility: Sanatorio Allende
city: La Rioja
country: Argentina
facility: Fundacion CORI para la Investigacion y Prevencion del Cancer
city: Rosario
country: Argentina
facility: Centro Medico IPAM
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Nedlands
country: Australia
facility: One Clinical Research Perth
state: Western Australia
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
state: Pará
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre HCPA PPDS
state: Pará
city: Caxias Do Sul
country: Brazil
facility: Universidade de Caxias do Sul
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundacao Pio XII Hospital de Cancer de Barretos
state: São Paulo
city: JAU
country: Brazil
facility: Fundação Doutor Amaral Carvalho - Hospital Amaral
state: São Paulo
city: Sao Jose Do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: São Paulo
city: São Paulo
country: Brazil
facility: Instituto Brasileiro de Controle Do Câncer IBCC
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - PPDS
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent's Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: