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
The main objective of the intervention(s) being evaluated by the clinical trial. Learn more
Treatment
Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
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

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.