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

March 20, 2025 updated by: Mabwell (Shanghai) Bioscience Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Tumor Hospital
        • Principal Investigator:
          • Shusuan JIANG
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Principal Investigator:
          • Hongqian Guo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntary participation
  • Age 18-80
  • ECOG 0-1
  • Histologically confirmed inoperable locally advanced or metastatic urothelial carcinoma (including bladder, renal pelvis and ureter). Mixed histology with squamous or adenomatous differentiation is allowed if urothelial carcinoma differentiation is >50%.
  • Has not received any systemic treatment for locally advanced or metastatic urothelial carcinoma
  • At least 1 measurable target lesion that satisfies RECIST v1.1 definition. If the patient has received radiotherapy, the target lesion needs to be outside the radiation field or has demonstrated clear progression after radiotherapy.
  • Life expectancy over 12 weeks
  • Appropriate hematological and organ functions
  • Agree to contraceptive measures until 180 days after the last dose of study drug administration
  • Able to understand and follow study visits, treatment, laboratory assessment and other procedures

Exclusion Criteria:

  • Other concurrent malignancy within 3 years prior to randomization
  • Active autoimmune disease requiring systemic treatment within 2 years prior to randomization. Having received high dose corticosteroid (>10mg/day prednisolone equivalent) or other immunosuppressive agents.
  • Severe cardiovascular or cerebral vascular thrombo-embolic events within 6 months prior to randomization
  • Major surgery within 28 days prior to randomization, except for minor procedures that the PI considers not to impact study participation. Live vaccine within 28 days prior to randomization or planning to take live vaccine during the study. Radiotherapy or bladder infusion therapy within 21 days prior to randomization. Use of strong CYP3A4 inhibitors within 14 days prior to randomization.
  • Lung effusion or ascites that require treatment within 14 days prior to randomization. Cancer-related severe uncontrolled bone pain or spinal cord compression within 14 days prior to randomization. Active infection that requires systemic antibiotic treatment within 7 days prior to randomization.
  • Have received prior treatment with anti-PD-1, anti-PD-L1/PD-L2 or anti-CTLA-4 therapies. Have received prior treatment with Nectin-4 targeted therapy or ADC with MMAE as payload. Have received allogeneic hematological stem cell transplantation or solid organ transplant.
  • Toxicities from previous cancer treatment (radiotherapy, chemotherapy or surgery) that have not recovered to grade 0-1 according to CTCAE v5.0, except for alopecia and skin hyperpigmentation.
  • Severe dry eyes, active keratitis, corneal ulceration or other risk factors for corneal diseases where the PI judges to be not suited for this study
  • Preexisting grade ≥ 2 neuropathy prior to randomization
  • Other uncontrolled serious illness
  • Brain metastasis or meningeal carcinomatosis
  • HBsAg positive, and HBV-DNA copy number positive ; HCV-Ab positive and HCV-RNA positive; HIV-Ab positive
  • Known allergy to the study drug or components of the study drug
  • Drug abuse or psychiatric disorder that would impact study compliance
  • Other circumstances that the PI judges to be not suitable for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
9MW2821+toripalimab
Drug: 9MW2821
a nectin-4 ADC with MMAE payload
Drug: Toripalimab (JS001 )
anit-PD-1 antibody
Other Names:
  • JS001
  • toripalimab
Active Comparator: Arm B
9MW2821 monotherapy
Drug: 9MW2821
a nectin-4 ADC with MMAE payload

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: 3 yeras
Objective Response Rate based on BICR
3 yeras

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other efficacy endpoints
Time Frame: 3 years
Overall survival; progression-free survival, duration of response, disease control rate, objective response rate based on investigator assessment and BICR
3 years
Safety assessment
Time Frame: 3 years
Incidences, severity and rates of treatment-emergent adverse events and treatment-related adverse events as assessed by CTCAE v5.0. Incidence and rates serious adverse events. Frequency of clinically significant abnormalities in physical examination, safety laboratory tests, urinalysis, vital signs, and 12-Lead ECG record.
3 years
Immunogenicity
Time Frame: 3 years
Incidence, rates of ADA and NAb development. Titer of ADA and NAb.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9MW2821-CP203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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