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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.