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

Mirati Therapeutics Inc.86 enrolled

Overview

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.

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. This study was terminated prior to phase 2 initiating. Only phase 1 of the study was conducted.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease

Interventions

MRTX849DRUG

KRAS G12C Inhibitor

TNO155DRUG

SHP2 Inhibitor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Local Institution - 002-805

Los Angeles, California, United States

Local Institution - 002-803

Orange, California, United States

Outcomes

Primary Outcomes

Characterize the safety of MRTX849 and TNO155 in patients having advanced solid tumor malignancies with KRAS G12C mutation.

Number of participants with treatment related adverse events

Time frame: 20 months

Evaluate the pharmacokinetics of MRTX849 and TNO155

Blood plasma concentration

Time frame: 20 months

Secondary Outcomes

Establish maximum tolerated dose

Number of participants with dose limiting toxicity

Time frame: 12 months

Evaluate clinical activity of MRTX849

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

Time frame: 20 months

Data from ClinicalTrials.gov

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