RecruitingPhase 2NCT05918107

A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM

Phase II Clinical Trial to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetic Characteristics of PM8002 Injection Combined With Standard Chemotherapy in the First-line Treatment of Subjects With Inoperable Malignant Mesothelioma


Sponsor

Biotheus Inc.

Enrollment

55 participants

Start Date

Aug 13, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with pemetrexed and platinum as first line treatment for MPM.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called PM8002 (which combines an anti-cancer antibody with an anti-blood-vessel agent) together with standard chemotherapy as the first treatment for people with malignant mesothelioma — a rare cancer most often found in the lining of the lungs, usually linked to asbestos exposure. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with malignant mesothelioma confirmed by tissue biopsy, and surgery is not an option - You have not received any prior systemic (whole-body) anti-cancer treatment (or finished adjuvant chemotherapy more than 6 months before your cancer came back) - You have at least one measurable tumor on imaging scans - Your organ function (blood, liver, kidneys) is adequate - You are in reasonably good physical condition (able to carry out light activity) - Your expected survival is at least 12 weeks **You may NOT be eligible if:** - You have active, symptomatic brain or spinal cord metastases - You have had another active cancer within the past 5 years (with some exceptions for easily cured skin cancers) - You have a severe allergy history or known allergy to any component of the study drugs - You have other serious uncontrolled medical conditions 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

DRUGPM8002

IV infusion

DRUGPemetrexed

IV infusion

DRUGCisplatin

IV infusion

DRUGCarboplatin

IV infusion


Locations(1)

Jilin Provincial Tumor Hospital

Changchun, China

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NCT05918107