RecruitingPhase 1NCT06227377
QTX3034 in Patients With KRAS G12D Mutation
A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation
Sponsor
Quanta Therapeutics
Enrollment
250 participants
Start Date
Feb 5, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria5
- 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
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Interventions
DRUGQTX3034
QTX3034 will be administered at protocol defined dose
COMBINATION_PRODUCTCetuximab
Cetuximab will be administered at protocol defined dose.
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06227377
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