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Monoclonal Antibodies

IMM2902 for Solid Tumors

Phase 1
Recruiting
Research Sponsored by ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female subject must either be of non-reproductive potential or must have a negative urine or serum pregnancy test within 7 days prior to the first dose of IMM2902
Has at least non-irradiated evaluable disease per RECIST version 1.1
Must not have
Uncontrolled pulmonary, renal, or hepatic dysfunction
Known inherited or acquired bleeding disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests IMM2902, a special protein that targets and helps destroy cancer cells with high levels of HER2, in patients with advanced solid tumors.

Who is the study for?
Adults with advanced solid tumors expressing HER2 who have tried at least one systemic therapy can join this trial. Specific cohorts include those with certain types of breast or gastric cancers after multiple treatments. Participants must be over 18, weigh more than 30 kg, and have a life expectancy of at least 3 months.
What is being tested?
IMM2902, a novel bispecific antibody-receptor fusion protein targeting HER2/SIRPα is being tested for safety and effectiveness in patients with various advanced solid tumors that express the HER2 protein.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions to monoclonal antibodies such as infusion-related reactions, immune system effects causing inflammation in different organs, fatigue, allergic responses, and possibly others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant or cannot become pregnant, confirmed by a recent test.
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I have a tumor that can be measured and has not been treated with radiation.
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I can take care of myself but might not be able to do heavy physical work.
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I weigh more than 30 kg.
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I finished my radiation therapy at least 2 weeks ago.
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I am 18 years old or older.
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My diagnosis fits one of the specific criteria for the 5 study groups.
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I finished my last cancer treatment more than 2 weeks ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lung, kidney, or liver function is stable.
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I have a known bleeding disorder.
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I have received high doses of anthracyclines for my cancer.
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I have a specific heart condition.
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I have not received a live vaccine recently.
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I have recently been treated with specific drugs for HER2-positive cancer.
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I do not have any current infections.
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I have a history of certain blood disorders.
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I do not have uncontrolled diabetes, lung disease, or serious GI issues causing diarrhea.
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I have or had an autoimmune or inflammatory disorder.
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I have had a recent blood clot in my lung or deep veins.
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I am currently being treated for an infection.
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I have not been treated with CD47 or SIRPα-targeting drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose-Limiting Toxicity (DLT)
Number of patients with Adverse Events（AEs）
dose for expansion (RDE) of IMM2902
+1 more

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: IMM2902Experimental Treatment1 Intervention
IMM2902 Phase 1a Dose escalation: 0.03, 0.1, 0.25, 0.5, 1.0, 1.5, and 2.0 mg/kg through intravenous administration weekly up to 48 weeks. Phase 1b Dose expansion: A disease-specific dose expansion study in patients with locally advanced (unresectable) and/or metastatic breast with HER2-overexpression (Cohort 1) or HER2-low (Cohort 2), gastric/esophageal/gastroesophageal junction (GEJ) cancer with HER2-overexpression (Cohort 3) or HER2-low (Cohort 4) and other solid tumors with HER2-overexpression (Cohort 5) is aimed at further defining safety and characterizing efficacy. Dose expansion is through intravenous administration weekly up to 48 weeks.

Find a Location

Who is running the clinical trial?

ImmuneOnco Biopharmaceuticals (Shanghai) Co., LtdLead Sponsor
3 Previous Clinical Trials
232 Total Patients Enrolled
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.Lead Sponsor
13 Previous Clinical Trials
1,397 Total Patients Enrolled
1 Trials studying Breast Cancer
48 Patients Enrolled for Breast Cancer
Cheng Huang, MDStudy DirectorVP，Clinical Development
2 Previous Clinical Trials
216 Total Patients Enrolled

Media Library

IMM2902 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05076591 — Phase 1
Breast Cancer Research Study Groups: IMM2902
Breast Cancer Clinical Trial 2023: IMM2902 Highlights & Side Effects. Trial Name: NCT05076591 — Phase 1
IMM2902 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05076591 — Phase 1
~42 spots leftby Oct 2025
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