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

Phase 1

Not yet recruiting

• Conditions: Advanced Urothelial Carcinoma
• Interventions: Drug: 9MW2821; Drug: Toripalimab

• Registration Number: NCT06079112
• Lead Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-25
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-09
• Last Update Submitted: 2023-10-09
• Study Start: 2023-10-10
• Study First Posted: 2023-10-12
• Last Update Posted: 2023-10-12
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.
• Subjects are willing to follow study procedures.

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.
• Other serious or uncontrolled diseases, such as serious interstitial pneumonia/asthma, serious thromboembolic events, etc.
• Poorly controlled central nervous system metastases.
• Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
• History of drug abuse or mental illness.
• Known allergic sensitivity to any of the ingredients of the study drug.
• Any P-glycoprotein (P-gp) inducers/inhibitors or potent CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug.
• History of autoimmune disease requiring systemic treatment within 2 years before the first dose.
• Any live vaccines within 4 weeks before first dose of study drug or during the study.
• Use of any investigational drug or medical instruments within 28 days prior to the first dose of study drug.
• History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.
• Other conditions unsuitable into the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
9MW2821+Toripalimab	9MW2821	-
9MW2821+Toripalimab	Toripalimab	-

Primary Outcome Measures

Name	Time	Method
incidence of AE/SAE	Up to 24 months	adverse event(AE) 、serious adverse event(SAE)

Secondary Outcome Measures

Name	Time	Method
Time To Response, TTR	Up to 24 months	Time from the date of first infusion to the date of CR or PR
Overall Survival, OS	Up to 24 months	Time from the date of first infusion to the date of death
Pharmacokinetics parameter	Up to 12 months	drug concentration of 9MW2821
Objective Response Rate, ORR	Up to 24 months	complete response (CR) or partial response (PR)
Duration of Response, DOR	Up to 24 months	Time from the date of the first CR or PR to the earliest date of disease progression or death
Disease Control Rate, DCR	Up to 24 months	the percentage of subjects who experience CR, PR or stable disease (SD)
Progression-Free Survival, PFS	Up to 24 months	Time from the date of first infusion to the earliest date of disease progression or death
Immunogenicity parameter	Up to 12 months	Anti-Drug Antibody (ADA) of 9MW2821

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China