Vanderbilt Clinical Trials

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

Purpose

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

Conditions

Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Gastric Adenocarcinoma

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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 central nervous system (CNS) metastases or leptomeningeal disease requiring steroids. - Prior treatment with any anti-CD47 or anti-SIRPα agent. - Prior treatment with ramucirumab.

Study Design

Phase: Phase 2/Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Phase 2 is Open Label; Phase 3 is blinded

Arm Groups

Arm	Description	Assigned Intervention
Experimental Phase 2 - Arm A	Evorpacept (ALX148) 30 mg/kg every two weeks (Q2W) intravenous (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.	Drug: Evorpacept (ALX148) IV Q2W Drug: Trastuzumab IV Q2W Other names: Herceptin Drug: Ramucirumab IV Q2W Other names: Cyramza Drug: Paclitaxel IV Days 1, 8, and 15 of a 28-day cycle Other names: Taxol
Active Comparator Phase 2 - Arm B	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.	Drug: Trastuzumab IV Q2W Other names: Herceptin Drug: Ramucirumab IV Q2W Other names: Cyramza Drug: Paclitaxel IV Days 1, 8, and 15 of a 28-day cycle Other names: Taxol
Experimental Phase 3 - Arm A	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.	Drug: Evorpacept (ALX148) IV Q2W Drug: Trastuzumab IV Q2W Other names: Herceptin Drug: Ramucirumab IV Q2W Other names: Cyramza Drug: Paclitaxel IV Days 1, 8, and 15 of a 28-day cycle Other names: Taxol
Active Comparator Phase 3 - Arm B	Ramucirumab 8 mg/kg Q2W IV and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.	Drug: Ramucirumab IV Q2W Other names: Cyramza Drug: Paclitaxel IV Days 1, 8, and 15 of a 28-day cycle Other names: Taxol

More Details

Status: Active, not recruiting
Sponsor: ALX Oncology Inc.

Study Contact

Detailed Description

This is a randomized phase 2 (open-label) / 3 (blinded), 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. The Sponsor has decided not to proceed with the Phase 3 portion of the study due to strategic considerations.