What side effects are associated with this type of intervention?

Common side effects of KRAS G12C inhibitors like adagrasib include gastrointestinal issues (nausea, diarrhea), fatigue, and liver enzyme elevations. CDK4/6 inhibitors such as palbociclib often cause neutropenia, leukopenia, fatigue, nausea, and infections. General side effects of chemotherapy and targeted therapies for solid tumors can include myelosuppression, neuropathy, alopecia, mucositis, and increased risk of infections. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors that target specific genetic mutations and pathways. For instance, sotorasib is a KRAS G12C inhibitor approved for the treatment of non-small cell lung cancer (NSCLC) with the KRAS G12C mutation. Additionally, CDK4/6 inhibitors like palbociclib, ribociclib, and abemaciclib have been approved for the treatment of hormone receptor-positive, HER2-negative breast cancer. These approvals highlight the FDA's recognition of targeted therapies that inhibit specific molecular pathways in solid tumors.

What other types of research exist?

Promising novel alternatives for solid tumor patients in 2024 include: 1) Sotorasib (another KRAS G12C inhibitor) which has shown efficacy in KRAS G12C-mutant cancers. 2) Abemaciclib and Ribociclib (other CDK4/6 inhibitors) which are being explored in various solid tumors. 3) Immunotherapies such as Pembrolizumab and Nivolumab, which have broad applications across different solid tumors. 4) Targeted therapies like Entrectinib and Larotrectinib for tumors with specific genetic alterations (e.g., NTRK fusions).

← Back to Search

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

No Placebo-Only Group

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

Select...

My cancer cannot be removed by surgery or has spread.

Select...

My cancer has a specific KRAS G12C mutation.

Select...

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:

Select...

I do not have any other active cancer.

Select...

I have heart problems.

Select...

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

Select...

I experienced severe side effects from previous KRAS G12C or CDK4/6 inhibitor treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3790

MRTX849

2021

Completed Phase 1

~10

0 / 7Eligibility criteria met

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.