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Monoclonal Antibodies

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

Phase 1

Recruiting

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed metastatic adenocarcinoma of the colon or rectum that has progressed on/after prior treatment with an EGFR inhibitor (e.g., cetuximab or panitumumab)

Negative for acquired on-target EGFR alterations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 41 months

Awards & highlights

Study Summary

This trial studies the safety of a drug (GDC-1971) when used with other treatments for cancer. It tests different doses and looks at effects.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include typical reactions from targeted cancer therapies such as skin rash, diarrhea, abnormal liver blood tests, fatigue and allergic reactions. The exact side effects will be monitored closely given this is a safety-focused study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My cancer does not have EGFR mutations.

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I am fully active or can carry out light work.

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My cancer does not have KRAS gene changes.

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My cancer does not have the BRAF V600E mutation.

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My cancer has a specific EGFR mutation.

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My cancer does not have NRAS gene changes.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 41 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 41 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 41 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Dose-Limiting Toxicities (DLTs)

Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

Secondary outcome measures

Duration of Response (DOR) as Determined by Investigator According to RECIST v1.1

Objective Response Rate (ORR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

Plasma Concentration of GDC-1971

+2 more

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

Osimertinib

2017

Completed Phase 4

~1010

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,541 Previous Clinical Trials

567,971 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,768 Total Patients Enrolled

Media Library

Colorectal Cancer Research Study Groups: Dose-Finding Stage: Non-Small Cell Lung Cancer (NSCLC), Dose-Finding Stage: Colorectal Cancer (CRC), Dose Expansion Stage: NSCLC, Dose Expansion Stage: CRC

Colorectal Cancer Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT05954871 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacant spaces still available for this research trial?

"Affirmative. The information hosted on clinicaltrials.gov attests to this study's ongoing recruitment process, which began in August of 2023 and was most recently updated on the 16th of that month. This trial seeks 172 volunteers from a single medical centre."

Answered by AI

Has the Dose-Finding Stage: Non-Small Cell Lung Cancer (NSCLC) acquired FDA clearance?

"With a score of 1, our team at Power has cautiously determined that the safety of Dose-Finding Stage: Non-Small cell lung cancer (NSCLC) is relatively low as this study is in its initial phase and there are minimal data points supporting efficacy."

Answered by AI

What is the participant capacity for this investigation?

"Indeed, the information hosted on clinicaltrials.gov confirms that this investigation is actively looking for volunteers. This particular trial has been running since August 31st 2023 and was recently modified on August 16th of the same year. 172 individuals will be recruited from a singular centre to take part in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05954871.

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