GDC-1971 + Osimertinib/Cetuximab for Non-Small Cell Lung Cancer

Recruiting at16 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Genentech, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with certain types of advanced lung or colorectal cancer. Participants must have specific genetic mutations, good organ function, and a performance status indicating they can care for themselves. They should not have had recent major surgeries or treatments, no active infections like hepatitis or HIV, and no history of significant heart, liver, or eye disease.

Inclusion Criteria

My cancer does not have EGFR mutations.

I am fully active or can carry out light work.

My colon or rectum cancer has worsened after treatment with an EGFR inhibitor.

Exclusion Criteria

I have had pulmonary fibrosis, organizing pneumonia, or pneumonitis.

I have untreated or active brain metastases needing medication for symptoms.

My cancer has spread to the lining of my brain or spinal cord.

Treatment Details

Interventions

• Cetuximab (Monoclonal Antibodies)
• GDC-1971 (Monoclonal Antibodies)
• Osimertinib (Monoclonal Antibodies)

Trial Overview The study tests the safety and effectiveness of GDC-1971 when combined with Osimertinib for lung cancer patients or Cetuximab for colorectal cancer patients. It includes an initial phase to find the right dose followed by a phase to see how well it works at that dose.

Participant Groups

Group I: Dose-Finding Stage: Non-Small Cell Lung Cancer (NSCLC) Experimental Treatment 2 Interventions

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.

Group II: Dose-Finding Stage: Colorectal Cancer (CRC) Experimental Treatment 2 Interventions

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.

Group III: Dose Expansion Stage: NSCLC Experimental Treatment 2 Interventions

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.

Group IV: Dose Expansion Stage: CRC Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD