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

Sponsor
Genentech, Inc.
Study ID
NCT05487235
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors
  • Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 17, 2022
Status verified
Jul 2025
Primary completion
Jun 23, 2025
Completion
Jun 23, 2025

Study Design

Enrollment
57 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose-finding Stage: GDC-1971
    Participants will receive GDC-1971 tablet or capsule at assigned dose, orally once daily (QD) on Days 1-21 of each cycle, along with atezolizumab 1200 milligrams (mg) intravenous (IV) infusion once every 3 weeks (Q3W), until unacceptable toxicity or loss of clinical benefit. A subset of participants will participate in evaluations regarding tablet versus (vs) capsule formulations.
  • Experimental: Expansion Stage: GDC-1971
    Participants will receive GDC-1971 orally at the assigned dose QD on Days 1-21 of each cycle and atezolizumab 1200 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit. A subset of participants will participate in evaluations regarding tablet vs capsule formulation, the effect of food and acid-reducing agents on GDC-1971.

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 2.5 years ]

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