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Completed

NCT Number: NCT05178888

Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)

This study will evaluate the safety and clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation.

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 804, Orlando, Florida, United States

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About this study

This study will evaluate the pharmacokinetics and preliminary clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and palbociclib is a small molecule inhibitor of CDK 4 and 6.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
  • Unresectable or metastatic disease.
  • No available treatment with curative intent
  • Adequate organ function

Exclusion criteria

  • History of significant toxicity on prior KRAS G12C or CDK4/6 inhibitor therapies
  • History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter the absorption of study treatment or result in an inability to swallow
  • Other active cancer
  • Cardiac abnormalities

Treatment and study plan

MRTX849

Drug

KRAS G12C inhibitor

Other names: KRAS G12C, adagrasib

Palbociclib

Drug

CDK 4 and 6 inhibitor

Other names: IBRANCE

Primary outcomes

  1. 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.

    Time frame: 24 months

    Number of participants with treatment emergent adverse events

  2. Evaluate Pharmacokinetics of the combination regimen

    Time frame: 24 months

    Plasma concentration

  3. Establish Maximum Tolerated Dose

    Time frame: 24 months

    Number of patients with dose limiting toxicity

  4. Evaluate preliminary clinical activity of the combination regimen

    Time frame: 24 months

    Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)

Sponsors and collaborators

Lead sponsor

Mirati Therapeutics Inc.

Industry

Registry information

Official study title

A Phase 1/1b Trial of MRTX849 in Combination With Palbociclib in Patients With Advanced Solid Tumors With KRAS G12C Mutation

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 5, 2022
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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