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

Recruiting in Palo Alto (17 mi)

+16 other 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.

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

My cancer does not have EGFR mutations.

I am fully active or can carry out light work.

My cancer does not have KRAS gene changes.

My cancer does not have the BRAF V600E mutation.

My cancer has a specific EGFR mutation.

My cancer does not have NRAS gene changes.

My lung cancer has worsened after treatment with a specific lung cancer medication.

Exclusion Criteria

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

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

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

I am HIV positive.

I do not have conditions affecting my body's ability to absorb nutrients.

I have difficulty with blood draws or IV insertions due to poor vein access.

I have high calcium levels in my blood that aren't managed.

I have a history of eye disease.

I have a history of serious heart problems.

I have a significant history of liver problems.

I have not had a serious infection in the last 4 weeks.

Participant Groups

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.

4Treatment groups

Experimental Treatment

Group I: Dose-Finding Stage: Non-Small Cell Lung Cancer (NSCLC)Experimental Treatment2 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 Treatment2 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: NSCLCExperimental Treatment2 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: CRCExperimental Treatment2 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.

Cetuximab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Erbitux for:

Locally or regionally advanced squamous cell carcinoma of the head and neck
Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
BRAF V600E mutation-positive metastatic colorectal cancer

🇪🇺 Approved in European Union as Erbitux for: