A Study of Evorpacept (ALX148) in Patients with Advanced HER2+ Gastric Cancer (ASPEN-06)

ALX Oncology

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Gastric Cancer; Gastroesophageal Junction Adenocarcinoma; Gastric Adenocarcinoma

Treatments: Drug: Trastuzumab; Drug: Paclitaxel; Drug: Ramucirumab; Drug: Evorpacept (ALX148)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05002127

AT148006

Details and patient eligibility

About

A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma.

Full description

This is a randomized phase 2 (open-label) / 3 (double-blind), international, multi-center study of patients with metastatic HER2-overexpressing gastric/GEJ adenocarcinoma that has progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy and are suitable for chemotherapy (2nd-line or 3rd-line). Approximately 450 adult patients are expected to be enrolled in the study across both phases.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HER2-overexpressing advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on or after a prior HER2-directed agent and fluoropyrimidine- or platinum-containing chemotherapy (2nd-line or 3rd-line)
• Adequate Bone Marrow Function.
• Adequate Renal & Liver Function.
• Adequate Performance Status

Exclusion criteria

• Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
• Prior treatment with any anti-CD47 or anti-SIRPα agent.
• Prior treatment with ramucirumab.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 4 patient groups

Phase 2 - Arm A

Experimental group

Description:

Evorpacept (ALX148) 30 mg/kg Q2W IV, trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.

Treatment:

Drug: Evorpacept (ALX148)

Drug: Paclitaxel

Drug: Ramucirumab

Drug: Trastuzumab

Phase 2 - Arm B

Active Comparator group

Description:

Trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.

Treatment:

Drug: Paclitaxel

Drug: Ramucirumab

Drug: Trastuzumab

Phase 3 - Arm A

Experimental group

Description:

Evorpacept (ALX148) 30 mg/kg Q2W IV, trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.

Treatment:

Drug: Evorpacept (ALX148)

Drug: Paclitaxel

Drug: Ramucirumab

Drug: Trastuzumab

Phase 3 - Arm B

Active Comparator group

Description:

Ramucirumab 8 mg/kg Q2W IV and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.

Treatment:

Drug: Paclitaxel

Drug: Ramucirumab