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

NCT05487235 | Completed Phase 1 FDA Drug

• 2 other identifiers: GO437122021-006479-40
• Study Type: interventional
• Target: 57
• Locations: 6 countries
• Sites: 25

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

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants With Adverse Events (AEs)

  Up to approximately 2.5 years

• Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs

  Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)

• Percentage of Participants With Clinically Significant Change from Baseline in Clinical Laboratory Test Results

  Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)

• Percentage of Participants With Clinically Significant Change From Baseline in RR and QT Intervals as Measured by Electrocardiogram (ECG)

  Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)

• Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)

  From Day 1 to Day 21 of Cycle 1 of the dose finding stage

• Plasma Concentration of GDC-1971

  Up to approximately 2.5 years

Secondary Outcomes (13)

• Area Under the Concentration-Time Curve From Time 0 to 96 hours (AUC0-96 hr) Following GDC-1971 Capsule or Tablet Administration

  Up to approximately 2.5 years

• AUC From Time 0 to Infinity (AUCinf) Following GDC-1971 Capsule or Tablet Administration

  Up to approximately 2.5 years

• Cmax of GDC-1971 Following Capsule or Tablet Administration

  Up to approximately 2.5 years

• AUC 0-96 hr Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions

  Up to approximately 2.5 years

• AUC inf Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions

  Up to approximately 2.5 years

Study Arms (2)

Dose-finding Stage: GDC-1971

EXPERIMENTAL

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.

Drug: GDC-1971; Drug: Atezolizumab

Expansion Stage: GDC-1971

EXPERIMENTAL

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.

Drug: GDC-1971; Drug: Atezolizumab; Drug: Omeprazole

Interventions

GDC-1971 DRUG

Capsule or tablet administered orally.

Also known as: RO7517834, RLY-1971

Dose-finding Stage: GDC-1971; Expansion Stage: GDC-1971

Atezolizumab DRUG

Administered as IV infusion.

Also known as: RO5541267

Dose-finding Stage: GDC-1971; Expansion Stage: GDC-1971

Omeprazole DRUG

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

Expansion Stage: GDC-1971

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (25)

Sanatorio Allende

Córdoba, X5000JHQ, Argentina

Location

Fundacion CORI para la Investigacion y Prevencion del Cancer

La Rioja, F5300COE, Argentina

Location

Centro Medico IPAM

Rosario, S2013SBK, Argentina

Location

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Border Medical Oncology

Wodonga, New South Wales, 3690, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

One Clinical Research Perth

Nedlands, Western Australia, 6009, Australia

Location

Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

Curitiba, Pará, 81520-060, Brazil

Location

Hospital de Clinicas de Porto Alegre HCPA PPDS

Pôrto Alegre, Pará, 90035-903, Brazil

Location

ONCOSITE Centro de Pesquisa Clínica Em Oncologia

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Fundacao Pio XII Hospital de Cancer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Fundação Doutor Amaral Carvalho - Hospital Amaral

Jaú, São Paulo, 17210-080, Brazil

Location

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

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

Instituto Brasileiro de Controle Do Câncer IBCC

São Paulo, 03102-006, Brazil

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center - PPDS

Seoul, 05505, South Korea

Location

MeSH Terms

Interventions

atezolizumab; Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: August 4, 2022
• Study Start: August 17, 2022
• Primary Completion: June 23, 2025
• Study Completion: June 23, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

NZ (1); AR (3); CA (3); AU (5); BR (8); KR (5)