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

NCT ID: NCT05487235

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-17
• Study Completion Date: 2025-06-23

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.

Conditions

Advanced Solid Tumors; Metastatic Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose-finding Stage: GDC-1971

Participants will receive GDC-1971 tablet or capsule at assigned dose, orally once daily (QD) on Days 1-21 of each cycle, along with atezolizumab 1200 milligrams (mg) intravenous (IV) infusion once every 3 weeks (Q3W), until unacceptable toxicity or loss of clinical benefit. A subset of participants will participate in evaluations regarding tablet versus (vs) capsule formulations.

Group Type: EXPERIMENTAL

GDC-1971

Intervention Type: DRUG

Capsule or tablet administered orally.

Atezolizumab

Intervention Type: DRUG

Administered as IV infusion.

Expansion Stage: GDC-1971

Participants will receive GDC-1971 orally at the assigned dose QD on Days 1-21 of each cycle and atezolizumab 1200 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit. A subset of participants will participate in evaluations regarding tablet vs capsule formulation, the effect of food and acid-reducing agents on GDC-1971.

Group Type: EXPERIMENTAL

GDC-1971

Intervention Type: DRUG

Capsule or tablet administered orally.

Atezolizumab

Intervention Type: DRUG

Administered as IV infusion.

Omeprazole

Intervention Type: DRUG

Administered orally as tablet or capsule in the acid-reducing agent assessment.

Interventions

GDC-1971

Capsule or tablet administered orally.

Intervention Type: DRUG

Atezolizumab

Administered as IV infusion.

Intervention Type: DRUG

Omeprazole

Administered orally as tablet or capsule in the acid-reducing agent assessment.

Intervention Type: DRUG

Other Intervention Names

RO7517834, RLY-1971; RO5541267

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).

• 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

• 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

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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Sanatorio Allende

Córdoba, , Argentina

Fundacion CORI para la Investigacion y Prevencion del Cancer

La Rioja, , Argentina

Centro Medico IPAM

Rosario, , Argentina

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Border Medical Oncology

Wodonga, New South Wales, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Austin Hospital

Heidelberg, Victoria, Australia

One Clinical Research Perth

Nedlands, Western Australia, Australia

Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

Curitiba, Pará, Brazil

Hospital de Clinicas de Porto Alegre HCPA PPDS

Pôrto Alegre, Pará, Brazil

ONCOSITE Centro de Pesquisa Clínica Em Oncologia

Ijuí, Rio Grande do Sul, Brazil

Fundacao Pio XII Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

Fundação Doutor Amaral Carvalho - Hospital Amaral

Jaú, São Paulo, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

São José do Rio Preto, São Paulo, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

Instituto Brasileiro de Controle Do Câncer IBCC

São Paulo, , Brazil

Cross Cancer Institute

Edmonton, Alberta, Canada

Ottawa Hospital

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Auckland City Hospital

Auckland, , New Zealand

Chungbuk National University Hospital

Cheongju-si, , South Korea

National Cancer Center

Goyang-si, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Asan Medical Center - PPDS

Seoul, , South Korea

Countries

Argentina; Australia; Brazil; Canada; New Zealand; South Korea

Other Identifiers

2021-006479-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GO43712

Identifier Type: -

Identifier Source: org_study_id