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Adagrasib in Combination With TNO155 in Patients With Cancer (KRYSTAL 2)

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Mirati Therapeutics

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Metastatic Cancer
Advanced Cancer
Malignant Neoplastic Disease

Treatments

Drug: TNO155
Drug: MRTX849

Study type

Interventional

Funder types

Industry

Identifiers

NCT04330664
849-002
CA239-0017

Details and patient eligibility

About

This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in combination with TNO155 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 in combination with TNO155 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and TNO155 is a selective, orally bioavailable allosteric inhibitor of wild-type SHP2.

Enrollment

86 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 (phase 2 must be either Non-Small Cell Lung Cancer or Colorectal Cancer)
  • Unresectable or metastatic disease
  • No available treatment with curative intent
  • Adequate organ function

Exclusion criteria

  • History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
  • Other active cancer
  • Cardiac abnormalities

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

86 participants in 3 patient groups

Phase 1 Dose Exploration
Experimental group
Description:
Dose escalation of TNO155 to determine maximum tolerated dose of TNO155 in combination with MRTX849
Treatment:
Drug: TNO155
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 in combination with TNO155 to recommend Phase 2 regimens
Treatment:
Drug: TNO155
Drug: MRTX849
Phase 2
Experimental group
Description:
Separate cohorts of patients stratified by histological diagnosis for evaluation of clinical activity to evaluate clinical activity of MRTX849 and TNO155 in combination
Treatment:
Drug: TNO155
Drug: MRTX849

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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