Summary

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

Age: 18 Years and older

Gender: All

Start Date: 02/05/2024

Primary Completion Date (Estimated): 04/01/2027

Study Completion Date (Estimated): 04/01/2027

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: 18 Years and older

Gender: All

Accepts Healthy Volunteers: No

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