Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Participants With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Participants With Metastatic Colorectal Cancer

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Genentech, Inc.
Study ID
NCT05954871
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • GDC-1971 — DRUG
    GDC-1971 capsules or tablets will be administered as specified in each treatment arm.
  • Osimertinib — DRUG
    Osimertinib tablets will be administered as specified in each treatment arm.
  • Cetuximab — DRUG
    Cetuximab, solution for infusion will be administered as specified in each treatment arm.

Study Details

The main purpose of the study is to evaluate the safety of GDC-1971 in combination with either osimertinib or cetuximab. The study consists of a dose-finding stage followed by an expansion stage.

Key Dates

Start date
Jan 8, 2024
Status verified
Nov 2025
Primary completion
Sep 16, 2025
Completion
Sep 16, 2025

Study Design

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

Arms

  • Experimental: Dose-Finding Stage: Non-Small Cell Lung Cancer (NSCLC)
    Participants with unresectable, locally advanced or metastatic NSCLC will receive GDC-1971 at an assigned dose, orally, once daily (QD), on Days 1 to 28 of each 28-day cycle in combination with osimertinib, 80 milligrams (mg), orally, QD, on Days 1 to 28 of each cycle until disease progression or unacceptable toxicity.
  • Experimental: Dose-Finding Stage: Colorectal Cancer (CRC)
    Participants with metastatic CRC will receive GDC-1971, at an assigned dose, orally, QD, on Days 1 to 28 days of each 28-day cycle in combination with cetuximab, 500 milligrams per square meter (mg/m\^2), given by IV infusion on Days 1 and 15 of each cycle, until disease progression or unacceptable toxicity.
  • Experimental: Dose Expansion Stage: NSCLC
    Participants with unresectable, locally advanced or metastatic NSCLC will receive GDC-1971 at a dose determined in the dose finding stage, orally, QD, on Days 1 to 28 of each 28-day cycle in combination with osimertinib, 80 mg, orally, QD, on Days 1 to 28 of each cycle until disease progression or unacceptable toxicity.
  • Experimental: Dose Expansion Stage: CRC
    Participants with metastatic CRC will receive GDC-1971 at a dose determined in the dose finding stage, orally, QD, on Days 1 to 28 of each 28-day cycle in combination with cetuximab, 500 mg/m\^2, given by IV infusion on Days 1 and 15 of each cycle until disease progression or unacceptable toxicity.

Primary Outcome Measure

Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 [ Time Frame: Up to approximately 41 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
SCRI Oncology PartnersNashvilleTennessee37203-
START South Texas Accelerated Research Therapeutics-San AntonioSan AntonioTexas78229-

Find similar trials in Nashville, TN

By condition
Colorectal cancerLung cancer
By specialty
OncologyGI oncologyLung oncologyLung disease
By research site
SCRI Oncology Partners· Nashville, TNSTART South Texas Accelerated Research Therapeutics-San Antonio· San Antonio, TX

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