RECRUITING

QTX3034 in Patients With KRAS G12D Mutation

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Conditions

Solid Tumors

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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 QTX3034 as a single agent or in combination with cetuximab.

Official Title

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

Quick Facts

Study Start:2024-02-05
Study Completion:2027-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06227377

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 CriteriaExclusion Criteria
  1. * 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
  2. * Part 1: - Advanced solid tumors with at least 1 prior systemic therapy
  3. * Evaluable or Measurable disease per RECIST 1.1.
  4. * Parts 2 and 3: Measurable disease per RECIST 1.1.
  5. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  6. * Adequate organ function
  1. * Prior treatment with a KRAS inhibitor
  2. * Active brain metastases or carcinomatous meningitis
  3. * History of other malignancy within 2 years
  4. * Significant cardiovascular disease
  5. * Disease or disorder that may pose a risk to patient's safety

Contacts and Locations

Study Contact

Quanta Therapeutics Clinical Trials
CONTACT
415-599-3892
clinicaltrials@quantatx.com

Study Locations (Sites)

Sarah Cannon Research Institute (SCRI)
Denver, Colorado, 80218
United States
Yale Cancer Center
New Haven, Connecticut, 06511
United States
Florida Cancer Specialists
Sarasota, Florida, 34232
United States
Duke University
Durham, North Carolina, 27710
United States
SCRI- Nashville
Nashville, Tennessee, 37203
United States
MD Anderson
Houston, Texas, 77030
United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
United States
University of Utah, Huntsman Cancer Center
Salt Lake City, Utah, 84112
United States
NEXT Oncology Virginia
Fairfax, Virginia, 22031
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 Date2024-02-05
Study Completion Date2027-04-01

Study Record Updates

Study Start Date2024-02-05
Study Completion Date2027-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumors