Adagrasib + Palbociclib for Solid Tumors

Recruiting at 11 trial locations

Overseen By Mirati Therapeutics Study Locator Services

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mirati Therapeutics Inc.

Disqualifiers: Other active cancer, Cardiac abnormalities, others

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

Compensation: Varies

Number of Visits: Unknown

11 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing two pills, MRTX849 (adagrasib) and palbociclib, in patients with advanced cancers that have a specific genetic mutation called KRAS G12C. MRTX849 targets the faulty part of the cancer cell, while palbociclib stops the cells from growing. The goal is to see if these drugs can safely and effectively stop the cancer from progressing.

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12C. Participants must not have any curative treatment options available and should have adequate organ function. They can't join if they have another active cancer, had severe side effects from similar treatments before, or conditions affecting drug absorption.

Inclusion Criteria

My cancer cannot be removed by surgery or has spread.

My cancer has a specific KRAS G12C mutation.

There are no treatments that can cure my condition.

Exclusion Criteria

I do not have any other active cancer.

I have heart problems.

I have a history of serious gut issues that could affect medication absorption.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Dose escalation of MRTX849 and palbociclib to determine maximum tolerated dose in combination

24 months

Dose Expansion

Expansion cohorts to ensure sufficient safety experience, pharmacokinetic data, and early evidence of clinical activity

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRTX849
• Palbociclib

Trial Overview The study tests the combination of two drugs: Adagrasib (MRTX849) and Palbociclib on patients with advanced solid tumors harboring the KRAS G12C mutation to assess safety and effectiveness.

How Is the Trial Designed?

Group I: Dose Expansion Experimental Treatment 2 Interventions

Expansion cohorts may be implemented to ensure sufficient safety experience, pharmacokinetic data and early evidence of clinical activity of MRTX in combination with palbociclib.

Group II: Dose Escalation Experimental Treatment 2 Interventions

Dose escalation of MRTX849 and palbociclib to determine maximum tolerated dose in combination.

MRTX849 is already approved in United States, European Union for the following indications:

Approved in United States as Krazati for:

• Locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutations
• Locally advanced or metastatic colorectal cancer with KRAS G12C mutations

Approved in European Union as Krazati for:

• Non-small cell lung cancer with KRAS G12C mutations

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