Resumen

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

Edad: 18 años o más

Género: Todos

Fecha de inicio: 02/05/2024

Fecha de finalización principal (estimada): 04/01/2027

Fecha estimada de finalización del estudio: 04/01/2027

Acepta voluntarios sanos: No

Propósito y descripción del ensayo

Criterios de elegibilidad

Edad: 18 años o más

Género: Todos

Acepta voluntarios sanos: No

Criterios de inclusión:

* 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

Criterios de exclusión:

* 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