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

JRCT ID: jRCT2031220162

Registered date:25/06/2022

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: gastric/gastroesophageal junction adenocarcinoma
• Date of first enrollment: 23/08/2022
• Target sample size: 54
• Countries of recruitment: BELGIUM,Japan,CZECH REPUBLIC,Japan,FRANCE,Japan,ITALY,Japan,SINGAPORE,Japan,SOUTH KOREA,Japan,SPAIN,Japan,TAIWAN,Japan,UNITED KINGDOM,Japan,UNITED STATES,Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 and Liver Function.
-Adequate Performance Status.

Exclude criteria

-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.

Related Information

• Primary Sponsor: Fanning Philip
• Secondary ID(s): NCT05002127,2021-001008-14