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KRAS G12C Inhibitor

GDC-6036 for KRAS G12C-Mutated Cancers

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 documented advanced or metastatic solid tumor with KRAS G12C mutation.
Be older than 18 years old
Must not have
Clinically significant cardiovascular dysfunction or liver disease.
Active brain metastases.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up various timepoints from cycle 1 day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). a cycle is 21 days.
Awards & highlights

Summary

This trial is testing a new drug to see if it's safe and effective for treating cancer in people with a specific gene mutation.

Who is the study for?
This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12C. Participants must be able to use contraception and not donate eggs or sperm during the study. They can't join if they have serious heart or liver problems, active brain cancer spread, or issues absorbing medicine through their gut.Check my eligibility
What is being tested?
The study is testing the safety and effects of a new drug named GDC-6036, alone or combined with other cancer drugs like Atezolizumab and Cetuximab. It's in early stages (Phase I) to find out how much of the drug can be given safely and how it might help patients.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, fatigue, nausea, skin rash, increased risk of infections due to immune system changes caused by these medications. The exact side effects will vary depending on which drugs are used together.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has a specific KRAS G12C mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have serious heart or liver problems.
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I have cancer that has spread to my brain.
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I have a condition that affects how my body absorbs food.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~various timepoints from cycle 1 day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). a cycle is 21 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and various timepoints from cycle 1 day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). a cycle is 21 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Adverse Events (AEs)
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Plasma Concentrations of Erlotinib
+9 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Arm G: GDC-6036 + Inavolisib (Stage I and Stage II)Experimental Treatment2 Interventions
Participants with solid tumors will receive GDC-6036 in combination with inavolisib PO in Stage I. Participants with select solid tumors will be treated with GDC-6036 in combination with inavolisib PO in Stage II.
Group II: Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II)Experimental Treatment2 Interventions
Participants with solid tumors will receive GDC-6036 in combination with GDC-1971 PO in Stage I. Participants with select solid tumors will be treated with GDC-6036 in combination with GDC-1971 PO in Stage II.
Group III: Arm E: GDC-6036 + Erlotinib (Stage I and Stage II)Experimental Treatment2 Interventions
Participants with non-small cell lung cancer will receive GDC-6036 in combination with erlotinib.
Group IV: Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)Experimental Treatment2 Interventions
Participants with solid tumors will receive GDC-6036 in combination with bevacizumab.
Group V: Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)Experimental Treatment2 Interventions
Participants with colorectal cancer will receive GDC-6036 in combination with cetuximab.
Group VI: Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II)Experimental Treatment2 Interventions
Participants with non-small cell lung cancer will receive GDC-6036 in combination with atezolizumab.
Group VII: Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II)Experimental Treatment1 Intervention
Participants in Stage I will receive GDC-6036 administered orally once daily (PO QD). The dose will be increased in successive cohorts until a study-specific threshold is reached. Participants with select solid tumors will be treated with GDC-6036 PO QD in Stage II.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5280
Cetuximab
2011
Completed Phase 3
~2480
Inavolisib
2021
Completed Phase 2
~260
Erlotinib
2011
Completed Phase 4
~2290

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Colorectal cancer treatments often target specific genetic mutations to inhibit cancer growth and progression. For instance, KRAS G12C inhibitors like GDC-6036 specifically target the KRAS G12C mutation, which is a common driver in colorectal cancer, by blocking the mutant KRAS protein's activity, thereby halting tumor growth. This is crucial for patients as KRAS mutations are associated with poor prognosis and resistance to other treatments. Additionally, therapies targeting the epidermal growth factor receptor (EGFR) are used in patients without RAS mutations to prevent cancer cell proliferation. Anti-angiogenic agents, which inhibit blood vessel formation, are also employed to starve tumors of nutrients. Understanding these mechanisms helps in selecting the most effective treatment based on the tumor's genetic profile, improving patient outcomes.
A First-in-Human Phase I Study to Evaluate the ERK1/2 Inhibitor GDC-0994 in Patients with Advanced Solid Tumors.Radiogenomics Monitoring in Breast Cancer Identifies Metabolism and Immune Checkpoints as Early Actionable Mechanisms of Resistance to Anti-angiogenic Treatment.Exposure to sodium channel-inhibiting drugs and cancer survival: protocol for a cohort study using the QResearch primary care database.

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,542 Previous Clinical Trials
567,579 Total Patients Enrolled
Clinical TrialsStudy DirectorGenentech, Inc.
2,204 Previous Clinical Trials
889,808 Total Patients Enrolled

Media Library

GDC-6036 (KRAS G12C Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04449874 — Phase 1
Colorectal Cancer Research Study Groups: Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II), Arm E: GDC-6036 + Erlotinib (Stage I and Stage II), Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II), Arm G: GDC-6036 + Inavolisib (Stage I and Stage II), Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II), Arm C: GDC-6036 + Cetuximab (Stage I and Stage II), Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II)
Colorectal Cancer Clinical Trial 2023: GDC-6036 Highlights & Side Effects. Trial Name: NCT04449874 — Phase 1
GDC-6036 (KRAS G12C Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04449874 — Phase 1
~38 spots leftby Nov 2024