ASPEN-06: This study is evaluating whether adding immunotherapy (called Evorpacept) to chemotherapy and targeted therapy is safe and effective in people with advanced or metastatic HER2-overexpressing cancer of the stomach or gastro-oesophageal junctionA Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma

Trial purpose

Cancer treatment

Tumor type

Upper gastrointestinal tract

Age

18+

Trial acronym

ASPEN-06

Summary

This trial has two parts: Phase 2 (open-label) and Phase 3 (double-blind). In both phases, eligible participants will be randomly allocated (by chance) to one of two treatment arms.

In Phase 2 Arm A (Experimental), participants will receive Evorpacept (also known as ALX148) every 2 weeks intravenously (IV), plus Trastuzumab targeted therapy every 2 weeks IV, Ramucirumab targeted therapy every two weeks IV, and Paclitaxel chemotherapy via IV on Days 1, 8, and 15 of a 28-day cycle.

In Phase 2 Arm B (Active Comparator), participants will receive Trastuzumab every 2 weeks IV, Ramucirumab every 2 weeks IV and Paclitaxel via IV on Days 1, 8 and 15 of a 28-day cycle.

In Phase 3 Arm A (Experimental), participants will receive Evorpacept every 2 weeks IV, Trastuzumab every 2 weeks IV, Ramucirumab every 2 weeks IV, and Paclitaxel via IV on DAys , 8, and 15 of a 28-day cycle.

In Phase 3 Arm B (Active Comparator), participants will receive Ramucirumab every 2 weeks IV and Paclitaxel via IV on Days 1, 8 and 15 of a 28-day cycle. 

Conditions

This trial is treating people with advanced or metastatic HER2-overexpressing gastric or gastro-oesophageal junction adenocarcinoma who have progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy (2nd-line or 3rd-line)

No longer recruiting (closed or complete) hospitals