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

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Mirati Therapeutics

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Metastatic Cancer
Advanced Cancer
Malignant Neoplastic Disease

Treatments

Drug: MRTX849
Drug: Afatinib
Drug: Pembrolizumab
Drug: Cetuximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03785249
849-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

822 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

822 participants in 9 patient groups

Phase 1 Dose Exploration
Experimental group
Description:
Dose escalation of MRTX849 to determine maximum tolerated dose
Treatment:
Drug: MRTX849
Phase 1b Expansion
Experimental group
Description:
Expansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 to recommend Phase 2 regimens
Treatment:
Drug: MRTX849
Phase 2
Experimental group
Description:
Separate cohorts of patients stratified by histological diagnosis, prior treatment history or co-mutation status (e.g., STK11) for evaluation of clinical activity of MRTX849
Treatment:
Drug: MRTX849
Pilot Phase 1b Combination with Pembrolizumab
Experimental group
Description:
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with pembrolizumab in patients with NSCLC
Treatment:
Drug: Pembrolizumab
Drug: MRTX849
Pilot Phase 1b Combination with Cetuximab
Experimental group
Description:
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with CRC
Treatment:
Drug: Cetuximab
Drug: MRTX849
Pilot Phase 1b Combination with Afatinib
Experimental group
Description:
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with afatinib in patients with NSCLC
Treatment:
Drug: Afatinib
Drug: MRTX849
Phase 2 Combination with Cetuximab
Experimental group
Description:
Phase 2 evaluation of the clinical activity of MRTX849 in combination with cetuximab in patients with CRC
Treatment:
Drug: Cetuximab
Drug: MRTX849
Pilot Phase 1b Combination with Cetuximab in NSCLC
Experimental group
Description:
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with NSCLC
Treatment:
Drug: Cetuximab
Drug: MRTX849
Pilot Phase 1b Combination with Cetuximab in PDAC
Experimental group
Description:
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with pancreatic adenocarcinoma (PDAC)
Treatment:
Drug: Cetuximab
Drug: MRTX849

Trial contacts and locations

98

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Central trial contact

Mirati Therapeutics Study Locator Services

Data sourced from clinicaltrials.gov

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