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

PHASE2PHASE3RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-01-15

Primary completion: 2026-07-01

Study completion finish: 2028-08-01

Study type

TREATMENT

Phase

PHASE2

PHASE3

Trial ID

NCT05002127

Intervention or treatment

DRUG: Evorpacept (ALX148)

DRUG: Trastuzumab

DRUG: Ramucirumab

DRUG: Paclitaxel

Conditions

• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma
• Gastric Adenocarcinoma

Condition: Gastric Cancer, Gastroesophageal Junction Adenocarcinoma and more
DRUG: Evorpacept (ALX148) and other drugs
Clayton, Victoria, Australia and more
Sponsor: ALX Oncology Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Monash Medical Centre

Research sites nearby

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Monash Medical Centre
Clayton, Victoria, Australia
Icon Cancer Centre Southport
Southport, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Phase 2 - 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
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
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
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

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Phase 2	Percentage of patients with objective response per RECIST 1.1	Last randomized patient on study at least 16 weeks
Phase 3	Overall Survival	From the date of randomization to the date of death (due to any cause), up to 36 months postdose

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Study of Evorpacept (ALX148) in Patients with Advanced HER2+ Gastric Cancer (ASPEN-06)