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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

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

No Placebo-Only Group

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.

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.

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

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My advanced stomach cancer worsened after treatment with HER2 and chemotherapy.

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My bone marrow is working well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never been treated with anti-CD47 or anti-SIRPα drugs.

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I need steroids for my brain or spinal cord cancer symptoms.

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I have been treated with ramucirumab before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of randomization to the date of death (due to any cause), up to 36 months postdose

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Aspartate aminotransferase increased

Headache

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

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

~5190

Ramucirumab

2017