Adagrasib + Nab-Sirolimus for Non-Small Cell Lung Cancer

Recruiting at 8 trial locations

Overseen By Mirati Therapeutics Study

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mirati Therapeutics Inc.

Disqualifiers: Intestinal disease, Lung disease, Cardiac abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

6 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the safety, MTD and/or RP2D, PK, and clinical activity of the combination of adagrasib with nab-sirolimus in patients with advanced solid tumors/NSCLC with a KRAS G12C mutation.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

I have heart problems.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Escalation

Dose escalation of adagrasib and nab-Sirolimus to determine maximum tolerated dose in combination and evaluate the clinical efficacy in patients with solid tumors

30 months

Phase 2: Treatment

Evaluate the safety, tolerability, and clinical activity of adagrasib in combination with nab-sirolimus in patients with NSCLC

30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Adagrasib
• nab-Sirolimus

Trial Overview 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.

Participant Groups

Group I: Dose Escalation and Clinical Efficacy Experimental Treatment 2 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

Adagrasib is already approved in United States, European Union for the following indications:

Approved in United States as Krazati for:

• KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
• KRAS G12C-mutated locally advanced or metastatic colorectal cancer

Approved in European Union as Krazati for:

• KRAS G12C mutation non-small cell lung cancer

Who Is Running the Clinical Trial?

Mirati Therapeutics Inc.

Lead Sponsor

Trials

73

Recruited

8,900+

Dr. Charles M. Baum

Mirati Therapeutics Inc.

Chief Executive Officer since 2023

MD, PhD

Dr. Joseph Leveque

Mirati Therapeutics Inc.

Chief Medical Officer since 2021

MD

Aadi Bioscience, Inc.

Industry Sponsor

Trials

18

Recruited

580+