QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations

Description

Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.

Conditions

Advanced Solid Tumors

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Study Overview

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Study Details

Study overview

Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.

A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations

QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations

Condition
Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Grand Rapids

South Texas Accelerated Research Therapeutics, LLC Midwest, Grand Rapids, Michigan, United States, 49546

San Antonio

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

West Valley City

South Texas Accelerated Research Therapeutics Mountain Region, LLC, West Valley City, Utah, United States, 84119

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 G12V mutations 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 one prior systemic therapy.
  • * Evaluable and measurable disease per RECIST v1.1.
  • * Part 2 and 3: Measurable disease per RECIST v1.1.
  • * Active brain metastasis or carcinomatous meningitis
  • * Significant cardiovascular disease
  • * Active infection requiring intravenous (IV) antibiotics
  • * Prior treatment with a KRAS inhibitor

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Quanta Therapeutics,

Study Record Dates

2029-01-02