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Small Molecule Drug

Adagrasib + Palbociclib for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Mirati Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unresectable or metastatic disease.
Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
Must not have
Other active cancer
Cardiac abnormalities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Summary

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 the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include digestive issues, liver problems due to altered organ function, fatigue, blood cell count changes leading to increased infection risk or bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer cannot be removed by surgery or has spread.
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My cancer has a specific KRAS G12C mutation.
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There are no treatments that can cure my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any other active cancer.
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I have heart problems.
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I have a history of serious gut issues that could affect medication absorption.
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I experienced severe side effects from previous KRAS G12C or CDK4/6 inhibitor treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Characterize the number of patients with treatment emergent adverse events of the combination regimen in patients with advanced solid tumor malignancies with KRAS G12C mutation.
Establish Maximum Tolerated Dose
Evaluate Pharmacokinetics of the combination regimen
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment2 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 EscalationExperimental Treatment2 Interventions
Dose escalation of MRTX849 and palbociclib to determine maximum tolerated dose in combination.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~3880
MRTX849
2021
Completed Phase 1
~10

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for solid tumors often involve targeted therapies that focus on specific genetic mutations and pathways critical for cancer cell survival and proliferation. For example, MRTX849 (adagrasib) is a KRAS G12C inhibitor that targets a specific mutation in the KRAS gene, which is frequently involved in the growth of various cancers. By inhibiting this mutation, adagrasib can effectively halt cancer cell proliferation. Similarly, palbociclib is a CDK4/6 inhibitor that disrupts the cell cycle by inhibiting cyclin-dependent kinases 4 and 6, leading to cell cycle arrest and reduced tumor growth. These targeted therapies are significant for solid tumor patients as they offer more personalized and potentially more effective treatment options with fewer side effects compared to traditional chemotherapy.

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor
70 Previous Clinical Trials
8,118 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,559 Previous Clinical Trials
3,383,705 Total Patients Enrolled

Media Library

Solid Tumors Clinical Trial 2023: MRTX849 Highlights & Side Effects. Trial Name: NCT05178888 — Phase 1
~3 spots leftby Sep 2025
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