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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
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
No Placebo-Only Group

Study 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.

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%
Aspartate aminotransferase increased
9%
Musculoskeletal pain
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Insomnia
6%
Transaminases increased
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~8090
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
890 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,597 Previous Clinical Trials
3,185,729 Total Patients Enrolled

Media Library

Evorpacept (ALX148) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05002127 — Phase 2 & 3
Gastroesophageal Junction Adenocarcinoma Research Study Groups: Phase 2 - Arm B, Phase 3 - Arm A, Phase 3 - Arm B, Phase 2 - Arm A
Gastroesophageal Junction Adenocarcinoma 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you tell me about other research that has been conducted using Trastuzumab?

"As of now, there are 1053 different clinical trials underway that are investigating Trastuzumab. Of those, 270 are in Phase 3. Even though a majority of the research is being conducted in Seattle, Washington, there are 56027 different locations running trials for Trastuzumab across the globe."

Answered by AI

What conditions does Trastuzumab seek to alleviate?

"Trastuzumab is an effective treatment for metastatic bladder cancer, inflammatory breast cancer, and acquired immunodeficiency syndrome."

Answered by AI

Can new patients join this ongoing research project?

"From what is available on clinicaltrials.gov, it seems that the trial is still looking for more participants. The study was initially posted on January 15th, 2022 and the last update was on August 17th, 2022."

Answered by AI
~238 spots leftby Jul 2026