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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Urothelial Carcinoma
• Intervention / Treatment: Drug: 9MW2821; Drug: Toripalimab

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jun Guo, Professor; Phone Number: 010-88196358; Email: guoj307@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
      • Contact: Jun Guo, Professor; Phone Number: 010-88196358; Email: guoj307@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 9MW2821+Toripalimab	Drug: 9MW2821; 1.0/1.25/1.5 mg/kg, intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.; Other Names: 9MW2821 injection; Drug: Toripalimab; 240mg intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.; Other Names: Toripalimab injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of AE/SAE	adverse event(AE) 、serious adverse event(SAE)	Up to 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 10, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Transitional Cell
• Other Study ID Numbers: 9MW2821-2023-CP104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No