QTX3046 in Patients With KRAS G12D Mutations

Description

Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in combination with cetuximab.

Conditions

Advanced Solid Tumor

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Study Overview

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Study Details

Study overview

Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in combination with cetuximab.

A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of QTX3046 in Patients With Advanced Solid Tumors With KRAS G12D Mutations

QTX3046 in Patients With KRAS G12D Mutations

Condition
Advanced Solid Tumor
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

Salt Lake City

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

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 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

2027-07-01