Open Actively Recruiting

QTX3034 in Patients With KRAS G12D Mutation

About

Brief Summary

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

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

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Study Stats
Protocol No.
24-6263
Category
Colorectal Cancer
Lung Cancer
Other Cancer
Pancreatic Cancer
Contact
JENNA DAVIS
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT06227377
For detailed technical eligibility, visit ClinicalTrials.gov.