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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

• Verified date: May 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
• 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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Metastatic Solid Tumors
• Neoplasms

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
Argentina	Centro de Investigación Clínica ? Clínica Viedma	Viedma
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 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