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

NCT06592326 | Recruiting Phase 3 DMC

• 1 other identifier: 9MW2821-CP302
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (2)

• BICR-PFS

  Progression-free survival, assessed by BICR

  up to 50 months

• OS

  Overall Survival

  up to 50 months

Secondary Outcomes (6)

• ORR

  Up to 50 months

• DCR

  Up to 50 months

• DoR

  Up to 50 months

• PFS

  Up to 50 months

• AE/SAE

  Up to 50 months

Study Arms (2)

9MW2821+Toripalimab

EXPERIMENTAL

9MW2821+Toripalimab

Drug: 9MW2821; Drug: Toripalimab

Gemcitabine+Cisplatin/Carboplatin

ACTIVE COMPARATOR

Gemcitabine+Cisplatin/Carboplatin

Drug: Gemcitabine; Drug: Cisplatin/Carboplatin

Interventions

9MW2821 DRUG

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

9MW2821+Toripalimab

Toripalimab DRUG

Toripalimab, 240mg, intravenous (IV) infusion

Also known as: Toripalimab injection

9MW2821+Toripalimab

Gemcitabine DRUG

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

Also known as: Gemcitabine Hydrochloride for Injection

Gemcitabine+Cisplatin/Carboplatin

Cisplatin/Carboplatin DRUG

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

Also known as: Cisplatin for injection/Carboplatin Injection

Gemcitabine+Cisplatin/Carboplatin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40288679 DERIVED

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

toripalimab; Gemcitabine; Injections; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Central Study Contacts

Dingwei Ye, Professor

CONTACT

13701663571; fuscc2012@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: August 22, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)