QTX3034 in Patients With KRAS G12D Mutation

Description

Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.

Conditions

Solid Tumors

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Study Overview

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Study Details

Study overview

Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.

A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation

QTX3034 in Patients With KRAS G12D Mutation

Condition
Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Denver

Sarah Cannon Research Institute (SCRI), Denver, Colorado, United States, 80218

New Haven

Yale Cancer Center, New Haven, Connecticut, United States, 06511

Sarasota

Florida Cancer Specialists, Sarasota, Florida, United States, 34232

Durham

Duke University, Durham, North Carolina, United States, 27710

Nashville

SCRI- Nashville, Nashville, Tennessee, United States, 37203

Houston

MD Anderson, Houston, Texas, United States, 77030

San Antonio

South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States, 78229

Salt Lake City

University of Utah, Huntsman Cancer Center, Salt Lake City, Utah, United States, 84112

Fairfax

NEXT Oncology Virginia, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic
  • * Part 1: - Advanced solid tumors with at least 1 prior systemic therapy
  • * Evaluable or Measurable disease per RECIST 1.1.
  • * Parts 2 and 3: Measurable disease per RECIST 1.1.
  • * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • * Adequate organ function
  • * Prior treatment with a KRAS inhibitor
  • * Active brain metastases or carcinomatous meningitis
  • * History of other malignancy within 2 years
  • * Significant cardiovascular disease
  • * Disease or disorder that may pose a risk to patient's safety

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Quanta Therapeutics,

Study Record Dates

2027-04-01