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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
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 belowSelect...
My advanced stomach cancer worsened after treatment with HER2 and chemotherapy.
Select...
My bone marrow is working well.
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
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 • NCT0130172959%
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
890 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,201,110 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My advanced stomach cancer worsened after treatment with HER2 and chemotherapy.I have never been treated with anti-CD47 or anti-SIRPα drugs.My bone marrow is working well.I am physically active and can do most of my daily activities.I need steroids for my brain or spinal cord cancer symptoms.My kidney and liver are working well.I have been treated with ramucirumab before.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 - Arm B
- Group 2: Phase 3 - Arm A
- Group 3: Phase 3 - Arm B
- Group 4: Phase 2 - Arm A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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