RecruitingPhase 1NCT06256055

Phase 1 Study of UCMYM802 Injection in Mesothelin-positive Advanced Malignant Solid Tumors

A First-In-Human, Single Arm, Open-label, Phase 1 Dose-Escalation Study of UCMYM802 Injection in Mesothelin-positive Advanced Malignant Solid Tumors


Sponsor

UTC Therapeutics Inc.

Enrollment

24 participants

Start Date

Mar 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a first-in-human, single-arm, open-label, dose escalation clinical study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics, immunogenicity and preliminary efficacy of UCMYM802 (Circular mRNA encoding Anti-Mesothelin CAR-T) injection in patients with Mesothelin-positive advanced malignant solid tumors.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 trial tests a new drug called UCMYM802 — an antibody-drug conjugate (a targeted missile that delivers chemotherapy directly to cancer cells) — in patients with solid tumors that express a protein called mesothelin. Mesothelin is found on the surface of certain cancers including mesothelioma, pancreatic, lung, and ovarian cancer. This early-stage trial mainly assesses safety and dosing. **You may be eligible if...** - You are aged 18–70 with a confirmed solid tumor that tests positive for mesothelin - Your cancer has not responded to or you cannot tolerate standard treatments - You have at least one evaluable tumor on imaging - You can provide a tumor tissue sample (or agree to a biopsy) - Your overall health is adequate (good organ function, acceptable blood counts) **You may NOT be eligible if...** - Your tumor does not express mesothelin - You have active serious infections or other conditions making treatment unsafe - You have had prior treatments that would overlap with this drug - Your organ function is below the study's thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALUCMYM802 Injection

1×10\^8\~2×10\^9 cells will be infused intravenously for 4 times.


Locations(1)

Peking University Cancer Hospital & Institute

Beijing, China

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NCT06256055


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