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

Mabwell (Shanghai) Bioscience Co., Ltd.1 site in 1 country100 target enrollmentOctober 10, 2023

ConditionsAdvanced Urothelial Carcinoma

Interventions9MW2821 Toripalimab

Drugs9MW2821 Toripalimab

Overview

Phase: Phase 1
Intervention: 9MW2821
Conditions: Advanced Urothelial Carcinoma
Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Enrollment: 100
Locations: 1
Primary Endpoint: incidence of AE/SAE
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 10, 2023

End Date

December 31, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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
•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.

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 ≥
•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.