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
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.
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
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
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
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There are 13 Locations for this study
Duarte California, 91010, United States
La Rioja , F5300, Argentina
Darlinghurst New South Wales, 2010, Australia
Wodonga New South Wales, 3690, Australia
Bedford Park South Australia, 5042, Australia
Heidelberg Victoria, 3084, Australia
Nedlands Western Australia, 6009, Australia
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 1, Canada
Cheongju-si , 28644, Korea, Republic of
Seoul , 003-7, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
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