QTX3046: QTX3046 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 QTX3046 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 mutations 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 one prior systemic therapy.
* Evaluable and measurable disease per RECIST v1.1.
* Part 2 and 3: Measurable disease per RECIST v1.1
Exclusion Criteria:
* Active brain metastasis or carcinomatous meningitis
* Significant cardiovascular disease
* Active infection requiring intravenous (IV) antibiotics
* Prior treatment with a KRAS inhibitor
Other protocol-defined Inclusion/Exclusion Criteria may apply
Primary outcome measure(s)
Number of participants with Treatment-emergent Adverse Events (TEAEs) — up to 2 years Define 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.
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.
Trial sites (5)
Facility
City
Region
Status
South Texas Accelerated Research Therapeutics, LLC Midwest
Grand Rapids
Michigan
Duke Cancer Center
Durham
North Carolina
The University of Texas MD Anderson Cancer Center
Houston
Texas
South Texas Accelerated Research Therapeutics, LLC San Antonio
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.
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