Melanoma Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

232

Study ID:

NCT05487235

Recruitment Status:

Recruiting

Sponsor:

Genentech, Inc.

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There are 9 Locations for this study

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City of Hope
Duarte California, 91010, United States
Fundacion CORI para la Investigacion y Prevencion del Cancer
La Rioja , F5300, Argentina
Border Medical Oncology
Wodonga New South Wales, 3690, Australia
One Clinical Research Perth
Nedlands Western Australia, 6009, Australia
Ottawa Hospital
Ottawa Ontario, K1H 8, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 1, Canada
Chungbuk National University Hospital
Cheongju-si , 28644, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

232

Study ID:

NCT05487235

Recruitment Status:

Recruiting

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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