Clinical trial

A Phase 1/1b Trial of MRTX849 in Combination With BI 1701963 in Patients With Advanced Solid Tumors With KRAS G12C Mutation

Name

849-014

Description

This study will evaluate safety, tolerability, drug levels, molecular effects and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors that have a KRAS G12C mutation.

Trial arms

Trial start

2021-08-12

Estimated PCD

2022-11-02

Trial end

2022-11-15

Status

Completed

Phase

Early phase I

Treatment

MRTX849

KRAS G12C inhibitor

Arms:

Dose escalation, Dose expansion

Other names:

KRAS G12C inhibitor, adagrasib

BI 1701963

SOS1 Inhibitor

Arms:

Dose escalation, Dose expansion

Other names:

SOS1 Inhibitor

Size

Primary endpoint

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

20 months

Evaluate Pharmacokinetics of the combination regimen

20 months

Establish Maximum Tolerated Dose

12 months

Eligibility criteria

Inclusion Criteria: * Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 1b 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 7, 'type': 'ACTUAL'}}

Updated at

2022-12-08

1 organization

2 products

5 indications

Organization

Mirati Therapeutics

Product

MRTX849

Indication

Advanced Cancer

Indication