Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
ID06592326

A Randomized, Controlled, Open-label, Multicenter Phase 3 Study of 9MW2821 Plus Toripalimab Versus Standard Chemotherapy in First-line Locally Advanced or Metastatic Urothelial Cancer

Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2024-09-19

460

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness, safety, and immune response of a combination treatment of 9MW2821 and Toripalimab compared to standard chemotherapy for adults with locally advanced or metastatic urothelial cancer who have not had prior systemic treatment. This phase 3 randomized, controlled, open-label study involves multiple centers and aims to provide new options for this serious condition. Participants will be randomly assigned to receive either the experimental combination of 9MW2821 at 1.25 mg/kg and Toripalimab at 240 mg, both given by intravenous infusion, or standard chemotherapy consisting of Gemcitabine with either Cisplatin or Carboplatin, also given by intravenous infusion. The study includes two treatment groups and is designed to compare these approaches as first-line therapy. During the study, participants will undergo regular assessments including imaging to measure tumor response using criteria up to 50 months, overall survival tracking, and evaluations of side effects and immune responses. Researchers will monitor progression-free survival and other outcomes, along with safety and tolerability. Follow-up visits and evaluations will be conducted throughout the study period to gather comprehensive data on the treatments' impact and participant health.

CONDITIONS

Brief Title

9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent approved by the ethics committee
  • Male or female aged 18 to 80 years
  • ECOG performance status of 0 or 1
  • Histologically confirmed locally advanced or metastatic urothelial cancer
  • No prior systemic treatment for locally advanced or metastatic urothelial cancer
  • At least one measurable lesion per RECIST V1.1
  • Adequate tumor tissue available for testing
  • Suitable for cisplatin or carboplatin-based chemotherapy as assessed by investigator
  • Life expectancy greater than 12 weeks
  • Adequate organ function
  • Use of proper contraception methods
  • Willing to follow study procedures
Not Eligible

You will not qualify if you...

  • History of another cancer within the past 3 years
  • Autoimmune disease requiring systemic treatment within the past 2 years
  • Significant cardiac, cerebrovascular disease, or thrombosis within the past 6 months
  • Major surgery within 28 days, live vaccines within 28 days, radiotherapy or intravesical therapy within 21 days, or use of potent CYP3A4 inducers/inhibitors within 14 days
  • Large amounts of pleural fluid or ascites, uncontrolled bone pain or spinal compression within 14 days
  • Active infection requiring systemic treatment within 7 days
  • Previous treatment with PD-1, PD-L1, PD-L2, or CTLA-4 inhibitors
  • Previous treatment with antibody-drug conjugates targeting Nectin-4 or linked to MMAE
  • History of organ or stem cell transplantation
  • Grade 2 or higher toxicity from prior treatment (except alopecia and pigmentation)
  • Risk factors for severe dry eye, active keratitis, or corneal ulcer
  • Peripheral neuropathy grade 2 or higher
  • Serious uncontrolled chronic diseases
  • Uncontrolled brain metastases or carcinomatous meningitis
  • Active hepatitis B, C, or HIV infection
  • Known allergy to study drug ingredients
  • History of drug abuse or mental illness
  • Other conditions that would make participation unsuitable

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 50 months

Participants receive either 9MW2821 plus Toripalimab or standard chemotherapy with Gemcitabine plus Cisplatin or Carboplatin as first-line treatment for locally advanced or metastatic urothelial cancer.

Regular visits for treatment administration and assessments as per protocol

Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

D

Dingwei Ye, Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Bulumtatug Fuvedotin (BFv, 9MW2821), a next-generation Nectin-4 targeting antibody-drug conjugate, in patients with advanced solid tumors: a first-in-human, open-label, multicenter, phase I/II study.

J Zhang, R Liu, S Wang...

https://pubmed.ncbi.nlm.nih.gov/40288679