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

NCT ID: NCT06592326

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-22
• Study Completion Date: 2028-12-31

Brief Summary

This is a randomized, controlled, open-label, multicenter phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of 9MW2821 combined with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer.

Detailed Description

The study is planning to enroll approximately 460 participants with unresectable locally advanced or metastatic urothelial cancer who have not previously received systematic treatment.

Conditions

Urothelial Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

9MW2821+Toripalimab

9MW2821+Toripalimab

Group Type: EXPERIMENTAL

9MW2821

Intervention Type: DRUG

9MW2821, 1.25mg/kg, intravenous (IV) infusion

Toripalimab

Intervention Type: DRUG

Toripalimab, 240mg, intravenous (IV) infusion

Gemcitabine+Cisplatin/Carboplatin

Gemcitabine+Cisplatin/Carboplatin

Group Type: ACTIVE_COMPARATOR

Gemcitabine

Intervention Type: DRUG

Gemcitabine: 1000mg/m2, intravenous (IV) infusion

Cisplatin/Carboplatin

Intervention Type: DRUG

Cisplatin: 70mg/m2 or Carboplatin: AUC=4.5/5, intravenous (IV) infusion.

Interventions

9MW2821

9MW2821, 1.25mg/kg, intravenous (IV) infusion

Intervention Type: DRUG

Toripalimab

Toripalimab, 240mg, intravenous (IV) infusion

Intervention Type: DRUG

Gemcitabine

Gemcitabine: 1000mg/m2, intravenous (IV) infusion

Intervention Type: DRUG

Cisplatin/Carboplatin

Cisplatin: 70mg/m2 or Carboplatin: AUC=4.5/5, intravenous (IV) infusion.

Intervention Type: DRUG

Other Intervention Names

Toripalimab injection; Gemcitabine Hydrochloride for Injection; Cisplatin for injection/Carboplatin Injection

Eligibility Criteria

Inclusion Criteria

• Sign the informed consent form approved by IEC.
• Male or female subjects aged 18 to 80 years.
• ECOG status: 0 or 1.
• Histologically confirmed local advanced or metastatic urothelial cancer
• Previously untreated with local advanced or metastatic urothelial cancer
• At least one measurable lesion, according to RECIST V1.1.
• Adequate tumor tissues submitted for test
• Suitable for cisplatin/carboplatin-based chemotherapy assessed by investigator
• Life expectancy for more than 12 weeks.
• Adequate organ functions.
• Proper contraception methods.
• Willingness to follow the study procedures.

Exclusion Criteria

• History of another malignancy within 3 years.
• History of autoimmune disease requiring systemic treatment within 2 years.
• History of clinically significant cardiac/cerebrovascular diseases or thrombosis within 6 months.
• Major surgery treated within 28 days; Any live vaccines got within 28 days; Radiotherapy or Intravesical therapy treated within 21 days; Traditional Chinese medicine or any potent CYP3A4 inducers/inhibitors taken within 14 days.
• Lots of pleural fluid and ascites, uncontrolled bone pain or spinal compression existed within 14 days; Systemic treatment with active infection within 7 days.
• Previously treated with PD-1, PD-L1, PD-L2, CTLA-4 inhibitors; Previously treated with ADCs which target Nectin-4 or are conjugated with payload MMAE; Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
• Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.
• Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc.
• Peripheral neuropathy Grade ≥ 2.
• Any other serious chronic or uncontrolled disease.
• Uncontrolled central nervous system metastases or carcinomatous meningitis.
• Active HBV/HCV/HIV infection, etc.
• Known allergic sensitivity to any of the ingredients of the study drug.
• History of drug abuse or mental illness.
• Other conditions unsuitable into the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mabwell (Shanghai) Bioscience Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dingwei Ye, Professor

Role: CONTACT

fuscc2012@163.com

13701663571

Facility Contacts

Dingwei Ye, Professor

Role: primary

fuscc2012@163.com

13701663571

References

Zhang J, Liu R, Wang S, Feng Z, Yang H, Gao S, Li X, Yao X, Chen J, Gong Z, Li Y, Li X, Wang S, Hu C, Liu J, Zhang M, Yuan F, Shi B, Lou H, Zhao P, Qiu F, Guo H, Hu B, Xu D, Huang H, Zhang X, Feng M, Wang X, Li G, Liu D, Chen X, Wang P. 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. Ann Oncol. 2025 Aug;36(8):934-943. doi: 10.1016/j.annonc.2025.04.009. Epub 2025 Apr 25.

Reference Type: DERIVED

PMID: 40288679 (View on PubMed)

Other Identifiers

9MW2821-CP302

Identifier Type: -

Identifier Source: org_study_id