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NCT Number: NCT03785249

Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Malignant Neoplastic Disease Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 001-900, San Juan, PR, Puerto Rico

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About this study

This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.

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
  • Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts
  • Adequate organ function

Exclusion criteria

  • History of intestinal disease or major gastric surgery or inability to swallow oral medications
  • Other active cancer

Treatment and study plan

MRTX849

Drug

MRTX849 will be administered orally once or twice daily in a continuous regimen

Pembrolizumab

Drug

Pembrolizumab is administered as an intravenous infusion once every 3 weeks

Cetuximab

Drug

Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks

afatinib

Drug

Afatinib will be administered orally once a day in a continuous regimen

Primary outcomes

  1. Characterize the safety of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation

    Time frame: 20 months

    Number of participants with treatment related adverse events

  2. Evaluate the pharmacokinetics of MRTX849

    Time frame: 20 months

    Blood plasma concentration

  3. Evaluate clinical activity/efficacy of MRTX849

    Time frame: 20 months

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

Secondary outcomes

  1. Establish maximum tolerated dose

    Time frame: 12 months

    Number of participants with dose limiting toxicity

  2. Characterize safety and tolerability of MRTX849 in combination with selected therapeutic agents

    Time frame: 12 months

    Number of participants with dose limiting toxicity

  3. Evaluate the pharmacokinetics of new MRTX849 oral formulations

    Time frame: 6 months

    Blood plasma concentration

  4. Evaluate the pharmacokinetics of MRTX849 administered with food

    Time frame: 6 months

    Blood plasma concentration

Sponsors and collaborators

Lead sponsor

Mirati Therapeutics Inc.

Industry

Registry information

Official study title

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2018
Registry last updated
Sep 30, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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