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 advancedat a late stage, far along or metastatic solid tumors.
The study will have 2 stages- dosethe amount of medication taken finding stage and expansion stage. In expansion stage participants with non-small cell lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs programmed death ligand -1 high (NSCLC PD L-1 high), NSCLC PD L-1 low, head and neck squamous cell carcinomacancer arising from tissues that line organs (HNSCC) PD L-1 positive, BRAF wild type (BRAF WT) melanomaa type of cancer that develops from melanocytes, which are the cells that produce pigment generally in the skin (but can develop in other areas of the body) and any locally advanced or metastatic solid tumors will be enrolled.
Intervention / Treatment
- Drug: GDC-1971
- Drug: Atezolizumab
- Drug: Omeprazole
Inclusion Criteria:
- Has Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer 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 anaplastica term used to describe abnormal cancer cells that grow uncontrollably in the body and have little or no resemblence to regular cells lymphomacancers of the lymphatic system 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