What side effects are associated with this type of intervention?

Common treatments for colorectal cancer include chemotherapy agents such as fluorouracil and irinotecan, often combined with targeted therapies like cetuximab and bevacizumab. These treatments can cause a range of side effects. Chemotherapy agents are associated with myelotoxicity, including neutropenia and thrombocytopenia, as well as gastrointestinal issues like nausea and diarrhea. Cetuximab can cause severe skin reactions, hypomagnesemia, and infusion-related reactions. Bevacizumab may lead to hypertension, proteinuria, and an increased risk of gastrointestinal perforation. These side effects highlight the importance of monitoring and managing adverse events during treatment.

What prior FDA approvals exist?

Historically, the FDA has approved several treatments for colorectal cancer, including chemotherapy agents like fluorouracil, oxaliplatin, and irinotecan, as well as targeted therapies such as cetuximab and bevacizumab. Cetuximab, an EGFR inhibitor, is specifically used in patients without KRAS, NRAS, or BRAF mutations. For KRAS G12C mutations, targeted therapies like GDC-6036 represent a newer approach, focusing on inhibiting the specific mutation driving the cancer's growth. This is part of an evolving landscape in colorectal cancer treatment, aiming to provide more personalized and effective options for patients with specific genetic profiles.

What other types of research exist?

For colorectal cancer patients, promising alternatives to GDC-6036 include treatments involving bevacizumab, cetuximab, and panitumumab for KRAS wild-type tumors. Additionally, CMAB009 combined with irinotecan has shown promise as a second-line treatment. These alternatives have demonstrated efficacy in clinical trials and may be considered in consultation with a healthcare provider.

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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 from cycle 1 day 1 until 28 days after the final dose (or as specified in the protocol). a cycle is 21 days.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called GDC-6036 in patients with advanced or metastatic solid tumors that have a KRAS G12C mutation. The drug works by blocking a faulty part of the cancer cells' genetic code to stop their growth.

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.

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.

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

Select...

My cancer has a specific KRAS G12C mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have serious heart or liver problems.

Select...

I have cancer that has spread to my brain.

Select...

I have a condition that affects how my body absorbs food.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from cycle 1 day 1 until 28 days after the final dose (or as specified in the protocol). a cycle is 21 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from cycle 1 day 1 until 28 days after the final dose (or as specified in the protocol). a cycle is 21 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from cycle 1 day 1 until 28 days after the final dose (or as specified in the protocol). a cycle is 21 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With Adverse Events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2016

Completed Phase 3

~5860

Bevacizumab

2013

Completed Phase 4

~5540

Cetuximab

2011

Completed Phase 3

~2480

Inavolisib

2021

Completed Phase 2

~260

Erlotinib

2011

Completed Phase 4

~2290

0 / 4Eligibility criteria met

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.