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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05487235
Other study ID # GO43712
Secondary ID 2021-006479-40
Status Recruiting
Phase Phase 1
First received
Last updated
Start date August 17, 2022
Est. completion date May 31, 2025

Study information

Verified date June 2024
Source Genentech, Inc.
Contact GO43712 https://forpatients.roche.com/
Phone 888-662-6728 (U.S. Only)
Email global-roche-genentech-trials@gene.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 232
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GDC-1971
Capsule or tablet administered orally.
Atezolizumab
Administered as IV infusion.
Omeprazole
Administered orally as tablet or capsule in the acid-reducing agent assessment.

Locations

Country Name City State
Argentina Sanatorio Allende Cordoba
Argentina Fundacion CORI para la Investigacion y Prevencion del Cancer La Rioja
Argentina Centro Medico IPAM Rosario
Australia Flinders Medical Centre Bedford Park South Australia
Australia St Vincent's Hospital Sydney Darlinghurst New South Wales
Australia Austin Hospital Heidelberg Victoria
Australia One Clinical Research Perth Nedlands Western Australia
Australia Border Medical Oncology Wodonga New South Wales
Brazil Santa Casa de Misericordia de Belo Horizonte - PPDS Belo Horizonte MG
Brazil Universidade de Caxias do Sul Caxias Do Sul RS
Brazil Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner Curitiba PA
Brazil ONCOSITE Centro de Pesquisa Clínica Em Oncologia Ijuí RS
Brazil Fundação Doutor Amaral Carvalho - Hospital Amaral JAU SP
Brazil Hospital de Clinicas de Porto Alegre HCPA PPDS Porto Alegre PA
Brazil Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS Sao Jose Do Rio Preto SP
Brazil Instituto do Cancer do Estado de Sao Paulo - ICESP Sao Paulo SP
Brazil Instituto Brasileiro de Controle Do Câncer IBCC São Paulo SP
Canada Cross Cancer Institute Edmonton Alberta
Canada Ottawa Hospital Ottawa Ontario
Canada Princess Margaret Cancer Centre Toronto Ontario
Korea, Republic of Chungbuk National University Hospital Cheongju si
Korea, Republic of National Cancer Center Goyang-si
Korea, Republic of Asan Medical Center - PPDS Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of The Catholic University of Korea Seoul St. Mary?s Hospital Seoul
Korea, Republic of The Catholic University of Korea St. Vincent's Hospital Suwon-si
New Zealand Auckland City Hospital Auckland
Poland Uniwersytecki Szpital Kliniczny w Poznaniu Pozna?
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Clinica Universitaria Navarra (Madrid) Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain MD Anderson Cancer Center Madrid ? Espana Madrid
Spain Clinica Universidad de Navarra Pamplona Navarra
Spain NEXT Oncology-Hospital Quironsalud Madrid Pozuelo de Alarcon Madrid
Spain Hospital Universitario Virgen del Rocio Sevilla
Spain Hospital Universitario Virgen Macarena Sevilla
Spain Hospital Clinico Universitario de Valencia Valencia
United States City of Hope Duarte California

Sponsors (1)

Lead Sponsor Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Korea, Republic of,  New Zealand,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Adverse Events (AEs) Up to approximately 2.5 years
Primary 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)
Primary 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)
Primary 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)
Primary Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) From Day 1 to Day 21 of Cycle 1 of the dose finding stage
Primary Plasma Concentration of GDC-1971 Up to approximately 2.5 years
Secondary 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
Secondary AUC From Time 0 to Infinity (AUCinf) Following GDC-1971 Capsule or Tablet Administration Up to approximately 2.5 years
Secondary Cmax of GDC-1971 Following Capsule or Tablet Administration Up to approximately 2.5 years
Secondary AUC 0-96 hr Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions Up to approximately 2.5 years
Secondary AUC inf Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions Up to approximately 2.5 years
Secondary Cmax of GDC-1971 Following Tablet Administration Under Fasted and Fed Conditions Up to approximately 2.5 years
Secondary AUC 0-24 hr at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole Up to approximately 2.5 years
Secondary Cmax at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole Up to approximately 2.5 years
Secondary Objective Response Rate (ORR) Up to approximately 2.5 years
Secondary Duration of Response (DOR) Up to approximately 2.5 years
Secondary Progression Free Survival (PFS) Up to approximately 2.5 years
Secondary PFS Rate Month 6
Secondary Overall Survival (OS) Rate Months 6 and 12
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