QTX3034 in Patients With KRAS G12D Mutation

Recruiting now · Phase 1

Conditions studied: Solid Tumors

In brief

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

Key facts

Study ID

NCT06227377

Run by

Quanta Therapeutics

People needed

250

Starts

2024-02-05

Expected to finish

2027-04-01

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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