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Small Molecule Inhibitor
Adagrasib + Nab-Sirolimus for Non-Small Cell Lung Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Mirati Therapeutics Inc.
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 30 months
Awards & highlights
Study Summary
This trial will test a new combo of drugs to treat advanced solid tumors/lung cancer with a genetic mutation.
Who is the study for?
This trial is for adults with advanced solid tumors or non-small cell lung cancer (NSCLC) that have a specific genetic change called KRAS G12C mutation. They should not be candidates for surgery to remove the tumor and must not have any other curative treatment options available. Their body's major functions need to be stable, and they must have measurable signs of cancer according to certain medical criteria.Check my eligibility
What is being tested?
The study is testing a combination of two drugs: Adagrasib and nab-Sirolimus, in patients with advanced cancers that carry the KRAS G12C mutation. It aims to find out the safest dose levels, how the body processes these drugs, and their effectiveness against these types of cancers.See study design
What are the potential side effects?
Potential side effects from Adagrasib may include fatigue, nausea, diarrhea, liver enzyme changes, while nab-Sirolimus might cause mouth sores, rash or skin issues, increased blood sugar levels among others. The combination's side effects will also be studied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D)
Phase 1: Safety and tolerability in the study population.
Phase 2: Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) (Phase 2)
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC)
Maximum observed plasma concentration
Phase 1 and 2: Evaluate efficacy endpoints characterized by overall survival, progression-free survival, and duration of response in the study population.
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Dose Escalation and Clinical EfficacyExperimental Treatment2 Interventions
Dose escalation of adagrasib and nab-Sirolimus to determine maximum tolerated dose in combination and evaluate the clinical efficacy of adagrasib in combination with nab-sirolimus in patients with solid tumors (Phase 1) and NSCLC (Phase 2) harboring a KRAS G12C mutation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adagrasib
2023
Completed Phase 1
~20
nab-Sirolimus
2015
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Aadi Bioscience, Inc.Industry Sponsor
16 Previous Clinical Trials
462 Total Patients Enrolled
Mirati Therapeutics Inc.Lead Sponsor
70 Previous Clinical Trials
8,126 Total Patients Enrolled
Elise Walsh, MDStudy DirectorMirati Therapeutics
1 Previous Clinical Trials
86 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart problems.My cancer has a KRAS G12C mutation.My cancer cannot be removed by surgery or has spread.There are no treatments that can cure my condition.My organs are working well.I have a history of serious gut issues that could affect medication absorption.I have had lung conditions needing steroids or currently have active lung issues.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation and Clinical Efficacy
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.
Are there any vacancies left for prospective test subjects in this research?
"Clinicaltrials.gov reports that this study, which was unveiled on June 27th 2023 and last updated 13 days ago, is not currently enrolling patients. That said, there are 3373 alternative trials actively recruiting participants at the moment."
Answered by AI
What outcome is the research team looking to achieve with this experiment?
"This clinical study will measure its primary outcome, the safety and tolerability of the trial population over a thirty month period. Secondary outcomes include Cmax-nab-sirolimus and adagrasib's maximum observed plasma concentration, Tmax-nab-sirolimus and adagrasib's time to achieve maximal plasma concentration as well as efficacy endpoints characterized by overall survival rate, progression free survival duration, and response duration from date of randomization till progressive disease or death due to any cause."
Answered by AI
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