ACTIVE_NOT_RECRUITING

QTX3046 in Patients With KRAS G12D Mutations

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-05-30

Study Completion:2027-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06428500

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

South Texas Accelerated Research Therapeutics, LLC Midwest

Grand Rapids, Michigan, 49546

United States

Duke Cancer Center

Durham, North Carolina, 27705

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

South Texas Accelerated Research Therapeutics, LLC San Antonio

San Antonio, Texas, 78229

United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: Quanta Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-30

Study Completion Date2027-07-01

Study Record Updates

Study Start Date2024-05-30

Study Completion Date2027-07-01

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor