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

A

ALX Oncology

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Gastric Adenocarcinoma

Treatments

Drug: Evorpacept (ALX148)
Drug: Trastuzumab
Drug: Paclitaxel
Drug: Ramucirumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05002127
AT148006

Details and patient eligibility

About

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

Full description

This is a randomized phase 2 (open-label) / 3 (double-blind), 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.

Enrollment

450 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 CNS metastases or leptomeningeal disease requiring steroids.
  • Prior treatment with any anti-CD47 or anti-SIRPα agent.
  • Prior treatment with ramucirumab.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

450 participants in 4 patient groups

Phase 2 - Arm A
Experimental group
Description:
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.
Treatment:
Drug: Paclitaxel
Drug: Ramucirumab
Drug: Trastuzumab
Drug: Evorpacept (ALX148)
Phase 2 - Arm B
Active Comparator group
Description:
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.
Treatment:
Drug: Paclitaxel
Drug: Ramucirumab
Drug: Trastuzumab
Phase 3 - Arm A
Experimental group
Description:
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.
Treatment:
Drug: Paclitaxel
Drug: Ramucirumab
Drug: Trastuzumab
Drug: Evorpacept (ALX148)
Phase 3 - Arm B
Active Comparator group
Description:
Ramucirumab 8 mg/kg Q2W IV and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Treatment:
Drug: Paclitaxel
Drug: Ramucirumab

Trial contacts and locations

55

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Central trial contact

Philip Fanning, PhD; Sophia Randolph, MD, PhD

Data sourced from clinicaltrials.gov

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