Clinical trial NCT06592326: 9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer
Official title: A Randomized, Controlled, Open-label, Multicenter Phase 3 Clinical Study of 9MW2821 in Combination With Toripalimab Versus Standard Chemotherapy in First-line Locally Advanced or Metastatic Urothelial Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Urothelial Carcinoma
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: BICR-PFS
timeFrame: up to 50 months
measure: OS
timeFrame: up to 50 months
Secondary outcomes:
measure: ORR
timeFrame: Up to 50 months
measure: DCR
timeFrame: Up to 50 months
measure: DoR
timeFrame: Up to 50 months
measure: PFS
timeFrame: Up to 50 months
measure: AE/SAE
timeFrame: Up to 50 months
measure: Immunogenicity
timeFrame: Up to 50 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: