Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation

NCT05737706 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: CA246-00051133-001
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 14

Brief Summary

A Phase 1/2 study of MRTX1133 in solid tumors harboring a KRAS G12D mutation.

Conditions

Solid Tumor; Advanced Solid Tumor; Non-small Cell Lung Cancer; Colo-rectal Cancer; Pancreatic Adenocarcinoma

Keywords

Non-Small Cell Lung Cancer; NSCLC; colorectal cancer; CRC; PDAC; KRAS; G12D; Solid Tumor; Advanced Solid Tumor; Malignant; Pancreatic Cancer; Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (6)

• Phase 1: Number of Patients who Experience Dose-Limiting Toxicity

  21 Days

• Phase 1/1b: Number of patients who experience a treatment-related adverse event

  Up to 2 years

• Phase 2: Objective response rate (ORR)

  2 years

• Phase 2: Duration of response (DOR)

  2 years

• Phase 2: Progression free survival (PFS)

  2 years

• Phase 2: Overall survival (OS)

  2 years

Secondary Outcomes (6)

• Area under plasma concentration versus time curve (AUC)

  up to 4 days

• Time to achieve maximal plasma concentration (Tmax)

  up to 4 days

• Maximum observed plasma concentration (Cmax)

  up to 4 days

• Terminal elimination half-life (t1/2)

  up to 4 days

• Apparent total plasma clearance when dosed orally (CL/F)

  up to 4 days

Study Arms (2)

Phase 1/1B

EXPERIMENTAL

Dose Escalation/Evaluation

Drug: MRTX1133

Phase 2

EXPERIMENTAL

MRTX1133 recommended Phase 2 dose administered to separate cohorts of patients with selected solid tumor malignancies with KRAS G12D mutation to include the following: NSCLC, PDAC, CRC, Other Solid Tumors

Drug: MRTX1133

Interventions

MRTX1133 DRUG

KRAS G12D Inhibitor

Phase 1/1B; Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of a solid tumor malignancy harboring KRAS G12D mutation in tumor tissue or ctDNA.
• Unresectable or metastatic disease.
• Patients must have received standard therapies appropriate for their tumor type and stage; first-line treatment for PDAC for certain cohorts.
• Presence of tumor lesions to be evaluated per RECIST v1.1:
• in the Phase 1 dose escalation cohorts, patients must have measurable or evaluable disease.
• in the Phase 1b and Phase 2 cohorts, patients must have measurable disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function.
• Age ≥ 18 years

You may not qualify if:

• Active brain metastases or carcinomatous meningitis.
• Prior treatment with a KRAS G12D inhibitor (Phase 1b \& Phase 2 only).
• History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
• 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 oral medications.
• History of malignant small bowel obstruction.
• Cardiac abnormalities.

Sponsors & Collaborators

• Mirati Therapeutics Inc.: lead

Study Sites (14)

Local Institution - 311

Phoenix, Arizona, 85054, United States

Location

Local Institution - 309

New Haven, Connecticut, 06520 8028, United States

Location

Local Institution - 301

Lady Lake, Florida, 32159 8987, United States

Location

Local Institution - 306

Baltimore, Maryland, 21231, United States

Location

Local Institution - 308

Boston, Massachusetts, 02114 3117, United States

Location

Local Institution - 310

Boston, Massachusetts, 02215, United States

Location

Local Institution - 314

Grand Rapids, Michigan, 49546, United States

Location

Local Institution - 312

New York, New York, 10065 6800, United States

Location

Local Institution - 303

Nashville, Tennessee, 37203, United States

Location

Local Institution - 302

Houston, Texas, 77030, United States

Location

Local Institution - 304

San Antonio, Texas, 78229 3307, United States

Location

Local Institution - 313

San Antonio, Texas, 78229, United States

Location

Local Institution - 305

Fairfax, Virginia, 22031, United States

Location

Local Institution - 307

Seattle, Washington, 98109 1023, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colonic Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms

Interventions

KRASG12D inhibitor MRTX1133

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: March 6, 2023
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

US (14)