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QTX3034 in Patients With KRAS G12D Mutation

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion 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

Exclusion Criteria:

* 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

Other protocol-defined Inclusion/Exclusion Criteria may apply

About the study

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

What is being tested

Sponsor: Quanta Therapeutics · Participants: 250 · Started: Feb 5, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06227377

Locations in the U.S.

CaliforniaUCLA Hematology/Oncology, Los Angeles
ColoradoSarah Cannon Research Institute (SCRI), Denver
ConnecticutYale Cancer Center, New Haven
FloridaFlorida Cancer Specialists, Sarasota
Moffitt Cancer Center, Tampa
New YorkNYU Langone Health, New York
Montefiore Medical Center, The Bronx
North CarolinaDuke University, Durham
OklahomaStephenson Cancer Center, Oklahoma City
TennesseeSCRI- Nashville, Nashville
TexasMD Anderson, Houston
START San Antonio, LLC, San Antonio
UtahUniversity of Utah, Huntsman Cancer Center, Salt Lake City
VirginiaNEXT Oncology Virginia, Fairfax

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.