Aún no reclutaNCT07859085Registro de ClinicalTrials.gov

A Study to Evaluate the Safety and Activity of GDC-7035 With Anti-Cancer Therapies in Participants With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma

Colorectal Neoplasms · Pancreatic Ductal Adenocarcinoma

Pregúntale a WCR sobre este estudio Registro oficial ↗

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: Fase 1
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 388 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The primary purpose of this study is to evaluate the safety of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with KRAS G12D-mutated metastatic colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC). The study consists of a safety run-in period followed by a randomized/expansion period.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

Confirmed presence of the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation as documented through central laboratory testing or prior local laboratory testing
Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm

Exclusion Criteria:

Malabsorption syndrome or other conditions that would interfere with enteral absorption
Known and untreated, or active central nervous system (CNS) metastases
Known clinically significant liver disease
History of or active clinically significant cardiovascular dysfunction

Other protocol-defined inclusion/exclusion criteria may apply.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Sin enmascaramiento

Group A: GDC-7035 + mFOLFOX6 + Panitumumab

Participants with CRC will receive GDC-7035 in combination with modified (levo)leucovorin, 5-fluorouracil (5-FU), oxaliplatin (mFOLFOX6) and panitumumab as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 in combination with mFOLFOX6 and panitumumab at doses determined to be safe in the safety run-in period.

Drug: GDC-7035 · Biological: Panitumumab · Drug: mFOLFOX6

Group B: GDC-7035 + FOLFIRI + Panitumumab

Participants with CRC will receive GDC-7035 in combination with leucovorin, 5-FU, irinotecan (FOLFIRI), and panitumumab as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 in combination with FOLFIRI and panitumumab at doses determined to be safe in the safety run-in period.

Drug: GDC-7035 · Biological: Panitumumab · Drug: FOLFIRI

Group C: GDC-7035 + mFOLFIRINOX or GDC-7035 Monotherapy

Participants with PDAC will receive GDC-7035 in combination with modified leucovorin, 5-FU, irinotecan, oxaliplatin (mFOLFIRINOX) as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 as a single agent or in combination with mFOLFIRINOX at doses determined to be safe in the safety run-in period.

Drug: GDC-7035 · Drug: mFOLFIRINOX

Group D: GDC-7035 + Gem-nabP or GDC-7035 Monotherapy

Participants with PDAC will receive GDC-7035 in combination with gemcitabine and nab-paclitaxel (Gem-nabP) as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 as a single agent or in combination with Gem-nabP at doses determined to be safe in the safety run-in period.

Drug: GDC-7035 · Drug: Gem-nabP

GDC-7035 DRUG

Participants will receive GDC-7035 as per the schedule specified in the protocol.

Panitumumab BIOLOGICAL

Participants will receive panitumumab in accordance with the local prescribing information.

mFOLFOX6 DRUG

Participants will receive mFOLFOX6 in accordance with the local prescribing information.

FOLFIRI DRUG

Participants will receive FOLFIRI in accordance with the local prescribing information.

mFOLFIRINOX DRUG

Participants will receive mFOLFIRINOX in accordance with the local prescribing information.

Gem-nabP DRUG

Participants will receive Gem-nabP in accordance with the local prescribing information.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.