← Back to Search

Monoclonal Antibodies

Evorpacept Combo for Stomach Cancer

Phase 2 & 3
Recruiting
Research Sponsored by ALX Oncology Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Prior treatment with any anti-CD47 or anti-SIRPα agent
Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of randomization to the date of death (due to any cause), up to 36 months postdose
Awards & highlights

Summary

This trial is testing a new drug combination for treating HER2-overexpressing gastric/GEJ adenocarcinoma.

Who is the study for?
This trial is for adults with advanced HER2+ gastric or gastroesophageal junction cancer that's worsened after treatment with a HER2-targeted therapy and chemo. Participants must have good organ function and physical health. Those with brain metastases needing steroids, previous anti-CD47/SIRPα therapy, or ramucirumab treatment can't join.Check my eligibility
What is being tested?
The study tests Evorpacept (ALX148) combined with Trastuzumab, Ramucirumab, and Paclitaxel in patients whose stomach cancer has high levels of the HER2 protein. It aims to see if this combo helps more than current treatments.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, lowered blood cell counts leading to increased infection risk or bleeding problems, liver issues, nerve damage causing numbness or tingling sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My advanced stomach cancer worsened after treatment with HER2 and chemotherapy.
Select...
My bone marrow is working well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have never been treated with anti-CD47 or anti-SIRPα drugs.
Select...
I need steroids for my brain or spinal cord cancer symptoms.
Select...
I have been treated with ramucirumab before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of randomization to the date of death (due to any cause), up to 36 months postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization to the date of death (due to any cause), up to 36 months postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2
Phase 3

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Phase 3 - Arm AExperimental Treatment4 Interventions
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.
Group II: Phase 2 - Arm AExperimental Treatment4 Interventions
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.
Group III: Phase 2 - Arm BActive Control3 Interventions
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.
Group IV: Phase 3 - Arm BActive Control2 Interventions
Ramucirumab 8 mg/kg Q2W IV and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Ramucirumab
2017
Completed Phase 3
~5050
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

ALX Oncology Inc.Lead Sponsor
8 Previous Clinical Trials
849 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,629 Previous Clinical Trials
3,217,660 Total Patients Enrolled

Media Library

Evorpacept (ALX148) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05002127 — Phase 2 & 3
Stomach Cancer Research Study Groups: Phase 2 - Arm B, Phase 3 - Arm A, Phase 3 - Arm B, Phase 2 - Arm A
Stomach Cancer Clinical Trial 2023: Evorpacept (ALX148) Highlights & Side Effects. Trial Name: NCT05002127 — Phase 2 & 3
Evorpacept (ALX148) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05002127 — Phase 2 & 3
~195 spots leftby Jul 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top