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Monoclonal Antibodies

IMM2902 for Solid Tumors

Phase 1
Recruiting
Research Sponsored by ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights

Study Summary

This trial is testing a new drug, IMM2902, to see if it is safe and effective in treating patients with advanced solid tumors that express the HER2 protein.

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.Check my eligibility
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.See study design
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.

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

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

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.

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Who is running the clinical trial?

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.Lead Sponsor
12 Previous Clinical Trials
1,195 Total Patients Enrolled
1 Trials studying Breast Cancer
48 Patients Enrolled for Breast Cancer
ImmuneOnco Biopharmaceuticals (Shanghai) Co., LtdLead Sponsor
3 Previous Clinical Trials
232 Total Patients Enrolled
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

Frequently Asked Questions

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

What is the current enrollment rate for this research endeavor?

"Affirmative, the clinical trial is still in motion and looking for participants. According to information on clinicaltrials.gov, this study was first posted on June 20th 2022 with its most recent update happening July 21st 2022. The investigators are seeking 135 patients from 3 sites."

Answered by AI

To what extent can IMM2902 be detrimental to individuals?

"Our team at Power has assigned a score of 1 to IMM2902 due its status as a Phase 1 trial, indicating that there is currently scant data available on the efficacy and safety of this medication."

Answered by AI

Are there any remaining vacancies for participants in this experiment?

"Indeed, the information posted on clinicaltrials.gov indicates this trial is currently open for recruitment, having been initially listed on June 20th 2022 and last updated July 21st. The study aims to onboard 135 patients from three distinct sites."

Answered by AI
~49 spots leftby Mar 2025