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Small Molecule
Adagrasib + Durvalumab for KRAS-Mutated Lung and Gastrointestinal Cancer
Phase 1
Waitlist Available
Led By Marcelo V. Negrao, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Study Summary
This trial is studying the best dose of two drugs for people with KRAS-mutated cancer.
Who is the study for?
This trial is for adults (18+) with advanced non-small cell lung or gastrointestinal cancers that have a specific mutation (KRAS G12C). Participants must have measurable disease, be in good physical condition, and not planning to become pregnant. They should not have severe illnesses or conditions that could affect the study's outcome.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs, Adagrasib and Durvalumab, to determine a safe dosage for patients with certain mutations in their cancer cells. It involves people who've had various treatments before but still require therapy.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to Durvalumab, liver enzyme changes from both drugs, fatigue, skin rash, nausea and other digestive issues. The exact side effects will be monitored as part of determining the appropriate dose.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose Expansion CohortExperimental Treatment2 Interventions
Group II: Dose Confirmation CohortExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Adagrasib
2023
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,469 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,272 Previous Clinical Trials
288,612,675 Total Patients Enrolled
Mirati Therapeutics Inc.Industry Sponsor
70 Previous Clinical Trials
8,205 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have cancer that has spread to the lining of the brain and spinal cord.You have a weakened immune system.You have cancer that has spread to other parts of your body or is advanced and cannot be treated with surgery or radiation.You have any of the following heart problems.You have another type of cancer that could be confused with the cancer being studied.You have received high-dose radiation to the lungs within 3 months before starting the study treatment.You currently have brain metastases that are not under control.You have had significant coughing up of blood or bleeding within 4 weeks before starting the trial.You have tried other treatments in the past, including a medication targeting the KRAS G12C gene.You have HIV, hepatitis B, or hepatitis C infection.You have a specific mutation called KRAS G12C.You are able to perform daily activities with little to no assistance.You have a specific amount of disease that can be measured using a certain method.You have been diagnosed with certain types of cancers in the lungs or digestive system.You have a current or past autoimmune or inflammatory disease.You are expected to live for at least 3 more months.Your blood tests must show a certain level of white blood cells, platelets, and hemoglobin. Your liver and kidney function should also be within a specific range.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Confirmation Cohort
- Group 2: Dose Expansion Cohort
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.
What kinds of potential risks is the Dose Confirmation Cohort associated with?
"The safety of Dose Confirmation Cohort has been rated a 1 by our team due to its Phase 1 nature, which suggests that there is minimal data underpinning both the efficacy and security of this drug."
Answered by AI
Are any participants currently being enrolled in this research trial?
"This clinical trial, first posted on the 30th of October 2023 and last edited 28th April 2023 is no longer seeking patients. However, there are over 1,700 other trials recruiting volunteers at this moment."
Answered by AI
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