Your session is about to expire
← Back to Search
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
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
Study 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 belowSelect...
My cancer has a specific KRAS G12C mutation.
Timeline
Screening ~ 3 weeks3 visits
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.
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.
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,541 Previous Clinical Trials
567,645 Total Patients Enrolled
Clinical TrialsStudy DirectorGenentech, Inc.
2,201 Previous Clinical Trials
888,442 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man who agrees to use contraception or remain abstinent as required.I do not have serious heart or liver problems.I have cancer that has spread to my brain.My cancer has a specific KRAS G12C mutation.I have a condition that affects how my body absorbs food.
Research Study Groups:
This trial has the following groups:- Group 1: Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II)
- Group 2: Arm E: GDC-6036 + Erlotinib (Stage I and Stage II)
- Group 3: Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)
- Group 4: Arm G: GDC-6036 + Inavolisib (Stage I and Stage II)
- Group 5: Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II)
- Group 6: Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)
- Group 7: Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How is GDC-6036 commonly employed in the treatment of diseases?
"GDC-6036 is the go-to treatment for recurrent platinum-resistant epithelial ovarian cancer. However, it has also demonstrated efficacy in fighting malignant neoplasms, recurrent primary peritoneal cancer with sensitivity to platinum and cases of post chemotherapy disease progression."
Answered by AI
What other exploratory studies have been done for GDC-6036?
"At present, 758 clinical trials are examining GDC-6036. Of these studies, 168 have advanced to Phase 3 testing. Notably, the majority of research is conducted in New york City; however there are 40 178 sites running tests for this medication around the world."
Answered by AI
Has GDC-6036 been granted regulatory clearance by the FDA?
"The safety of GDC-6036, which is in the early stages of clinical trials, is judged to be a 1 based on our internal evaluation. Data collected so far has been limited and inconclusive regarding both efficacy and safety."
Answered by AI
To what extent is this experiment being administered in medical facilities?
"The study is recruiting patients at fourteen locations, such as Florida Cancer Specialists - Sarasota in Sarasota, UCSD Moores Cancer Center in La Jolla and Chao Family Comprehensive Cancer Center UCI in Orange. Additionally, there are eleven other sites involved."
Answered by AI
Is there scope for additional participants in this experiment?
"According to clinicaltrials.gov, this trial is still actively recruiting participants, with the initial posting occurring on July 29th 2020 and the last edit being done on November 14th 2022."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger