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A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-overexpressing gastric/gastroesophageal junction adenocarcinoma (ASPEN-06)

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

Fanning Philip

ALX Oncology Inc.

323 Allerton Ave, South San Francisco, CA, 94080, USA

info@alxoncology.com

Clinical trial contact

ICON Clinical Research GK

Kyutaromachi 4-chome 1-3, Chuo-ku, Osaka city, Osaka 541-0056, Japan

+81-6-4560-2001

ICONCR-Chiken@iconplc.com

Complete

July. 01, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

-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 and Liver Function.
-Adequate Performance Status.

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

Both

gastric/gastroesophageal junction adenocarcinoma

ALX148 30 mg/kg Q2W as an intravenous infusion on Days 1 and 15 of a 28-day cycle.
Trastuzumab will be administered at an initial dose of 6 mg/kg administered as an intravenous infusion, followed by 4 mg/kg intravenous infusion administered on Days 1 and 15 of a 28-day cycle.
Ramucirumab will be administered at a dose of 8 mg/kg Days 1 and 15 of a 28-day cycle by intravenous infusion.
Paclitaxel will be administered at a dose of 80 mg/m^2 Days 1, 8, and 15 of a 28-day cycle by intravenous infusion.

Phase 2:
-Percentage of patients with objective response per RECIST 1.1
Phase 3:
-Overall Survival

+81-3-3542-2511

May. 16, 2022

BELGIUM/CZECH REPUBLIC/FRANCE/ITALY/SINGAPORE/SOUTH KOREA/SPAIN/TAIWAN/UNITED KINGDOM/UNITED STATES