RecruitingPhase 2NCT06823427

9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma

A Randomized Phase II Trial to Evaluate 9MW2821 in Combination With Toripalimab Compared With 9MW2821 Monotherapy for the 1st Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma


Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Enrollment

60 participants

Start Date

Jan 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study will compare the efficacy of 9MW2821+toripalimab versus 9MW2821 monotherapy in locally advanced or metastatic urothelial carcinoma patients who have not received any systemic treatment in the metastatic or advanced setting.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for people with locally advanced cervical cancer that cannot be removed by surgery: a combination of 9MW2821 (a targeted antibody-drug) plus toripalimab (an immunotherapy), versus 9MW2821 alone. **You may be eligible if...** - You are 18–70 years old - You have locally advanced cervical cancer that cannot be surgically removed - You have not received prior systemic chemotherapy or immunotherapy for this cancer - Your cancer is confirmed by biopsy - You are in reasonably good physical health (ECOG score 0–1) - Your organ function (kidneys, liver, bone marrow) is within normal ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs (stage IVB) - You have already received chemotherapy or radiation for this cancer - You have active autoimmune disease - You are pregnant or breastfeeding - You have serious heart, lung, or liver 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

DRUG9MW2821

a nectin-4 ADC with MMAE payload

DRUGToripalimab (JS001 )

anit-PD-1 antibody


Locations(2)

Hunan Tumor Hospital

Changsha, Hunan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

View Full Details on ClinicalTrials.gov

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NCT06823427


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