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Clinical Trials in the USA / NCT06227377
Recruiting Phase 1

QTX3034 in Patients With KRAS G12D Mutation

NCT06227377 · tracked via the Priya Life Science USA tracker
Sponsor
Quanta Therapeutics
Phase
Phase 1
Started
2024-02-05
Last updated
2026-04-27

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

QTX3034Cetuximab

QTX3034: QTX3034 will be administered at protocol defined dose

Cetuximab: Cetuximab will be administered at protocol defined dose.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of participants with Dose Limiting Toxicities (DLTs) — up to 21 days
    DLTs will be defined as the occurrence of any of the toxicities as described in the protocol
  • Number of participants with Treatment-emergent Adverse Events (TEAEs) — up to 2 years
    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab

Trial sites (14)

FacilityCityRegionStatus
UCLA Hematology/Oncology Los Angeles California Recruiting
Sarah Cannon Research Institute (SCRI) Denver Colorado Recruiting
Yale Cancer Center New Haven Connecticut Recruiting
Florida Cancer Specialists Sarasota Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
NYU Langone Health New York New York Recruiting
Montefiore Medical Center The Bronx New York Recruiting
Duke University Durham North Carolina Recruiting
Stephenson Cancer Center Oklahoma City Oklahoma Recruiting
SCRI- Nashville Nashville Tennessee Recruiting
MD Anderson Houston Texas Recruiting
START San Antonio, LLC San Antonio Texas Recruiting
University of Utah, Huntsman Cancer Center Salt Lake City Utah Recruiting
NEXT Oncology Virginia Fairfax Virginia Recruiting

More Quanta Therapeutics trials in the USA

QTX3046 in Patients With KRAS G12D Mutations Active, not recruiting
QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations Active, not recruiting

Other trials for the same condition

A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers Active, not recruiting
REC-7735 in Participants With Solid Tumors Recruiting
A Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors Recruiting
A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies Recruiting
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06227377 on ClinicalTrials.gov ↗ ← All trials in the USA