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Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)

NCT ID: NCT04975256

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-28

Study Completion Date

2022-11-15

Brief Summary

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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.

Detailed Description

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This study will evaluate safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and BI 1701963 is a SOS1 pan-KRAS inhibitor.

Conditions

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Advanced Cancer Metastatic Cancer Malignant Neoplasm of Colon Malignant Neoplasm of Lung Malignant Neoplastic Disease

Keywords

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KRAS G12C SOS1 Inhibitor NSCLC CRC Non Small Cell Lung Cancer Colon Cancer Advanced Solid Tumor Metastatic Cancer Pancreatic Cancer adagrasib

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose escalation

Dose escalation of MRTX849 and BI 1701963 to determine maximum tolerated dose in combination

Group Type EXPERIMENTAL

MRTX849

Intervention Type DRUG

KRAS G12C inhibitor

BI 1701963

Intervention Type DRUG

SOS1 Inhibitor

Dose expansion

Expansion cohorts in NSCLC and CRC patients to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 in combination with BI 1701963

Group Type EXPERIMENTAL

MRTX849

Intervention Type DRUG

KRAS G12C inhibitor

BI 1701963

Intervention Type DRUG

SOS1 Inhibitor

Interventions

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MRTX849

KRAS G12C inhibitor

Intervention Type DRUG

BI 1701963

SOS1 Inhibitor

Intervention Type DRUG

Other Intervention Names

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KRAS G12C inhibitor adagrasib SOS1 Inhibitor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Mirati Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Chao, MD

Role: STUDY_DIRECTOR

Mirati Therapeutics

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Next Oncology

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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849-014

Identifier Type: -

Identifier Source: org_study_id