To hear about similar clinical trials, please enter your email below
Trial Title:
9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer
NCT ID:
NCT06592326
Condition:
Urothelial Carcinoma
Conditions: Official terms:
Carcinoma, Transitional Cell
Cisplatin
Carboplatin
Gemcitabine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
9MW2821
Description:
9MW2821, 1.25mg/kg, intravenous (IV) infusion
Arm group label:
9MW2821+Toripalimab
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Toripalimab, 240mg, intravenous (IV) infusion
Arm group label:
9MW2821+Toripalimab
Other name:
Toripalimab injection
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine: 1000mg/m2, intravenous (IV) infusion
Arm group label:
Gemcitabine+Cisplatin/Carboplatin
Other name:
Gemcitabine Hydrochloride for Injection
Intervention type:
Drug
Intervention name:
Cisplatin/Carboplatin
Description:
Cisplatin: 70mg/m2 or Carboplatin: AUC=4.5/5, intravenous (IV) infusion.
Arm group label:
Gemcitabine+Cisplatin/Carboplatin
Other name:
Cisplatin for injection/Carboplatin Injection
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Dingwei Ye, Professor
Phone:
13701663571
Email:
fuscc2012@163.com
Start date:
August 22, 2024
Completion date:
December 2028
Lead sponsor:
Agency:
Mabwell (Shanghai) Bioscience Co., Ltd.
Agency class:
Industry
Source:
Mabwell (Shanghai) Bioscience Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06592326
