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9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer

A Phase Ib/II, Open-label, Single Arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer

NCT06079112•Mabwell (Shanghai) Bioscience Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a phase Ib/II, open-label, multicenter clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of 9MW2821 combined with Toripalimab injection in subjects with local advanced or metastatic urothelial cancer.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Sign and date the informed consent form e approved by independent ethics committe.
•Male or female subjects aged 18 to 80 years (including 18 and 80 years).
•ECOG status of 0 or 1.
•Histologically or cytologically confirmed local advanced or metastatic urothelial cancer
•Subjects have received at least 1 line advanced standard therapy or were not treated before
•Subjects must submit tumor tissues for test
•Life expectancy of ≥ 12 weeks.
•Subjects must have measurable lesions according to RECIST (version 1.1).
•Adequate organ functions
•Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
+1 more criteria

Exclusion Criteria

•Anti-tumor treatment such as chemotherapy and radiotherapy within 21 days prior to the first dose of study drug.
•Major surgery within 28 days prior to first dose of study drug.
•PD-1/PD-L1/PD-L2 inhibitors used in the previous treatment for La/m UC.
•Previous treatment with ADCs conjugated with MMAE payload.
•Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.
•Peripheral neuropathy Grade ≥ 2.
•Poorly controlled blood sugar.
•Increased risks of corneal disease assessed by the investigator prior to the first dose of study drug.
•Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
•Active infections, such as uncontrolled HBV/HCV/HIV/TB infection, etc.
+11 more criteria

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

September 27, 2023

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2027

Last Updated

September 19, 2024

Enrollment

100

ESTIMATED participants

Conditions

Advanced Urothelial Carcinoma

Interventions

9MW2821

DRUG

Toripalimab

DRUG

Contacts

Jun Guo, Professor

CONTACT

010-88196358 guoj307@126.com

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RECRUITINGPHASE2

Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer

Inclusion Criteria

Exclusion Criteria

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