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Monoclonal Antibodies

IMM2902 for Solid Tumors

Phase 1

Waitlist Available

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks

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.

0 / 21Eligibility criteria met