Recruiting NCT07314723
9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 9MW2821, Toripalimab Injection.
- Who it may be relevant to
- Registry conditions: Urothelial Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single Arm, Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer
Overview
This is a single arm, open-label, multicenter phase II clinical study to evaluate the safety and efficacy of 9MW2821 combined with Toripalimab in perioperative patients with urothelial cancer.
Interventions
- Drug 9MW2821
9MW2821, 1.25mg/kg, intravenous (IV) infusion - Drug Toripalimab Injection
Toripalimab, 240mg, intravenous (IV) infusion
Primary outcome measures
- pCR (Arm 1 and 2) [Time frame: Up to 24 months]
- cCR (Arm 3) [Time frame: Up to 24 months]
Secondary outcome measures (9)
- cORR [Time frame: Up to 24 months]
- Pathological downstaging rate (Arm 1 and 2) [Time frame: Up to 24 months]
- DFS (Arm 1 and 2) [Time frame: Up to 24 months]
- Duration of clinical complete response (Arm 3) [Time frame: Up to 24 months]
- PFS (Arm 3) [Time frame: Up to 24 months]
- OS [Time frame: Up to 24 months]
- AE/SAE [Time frame: Up to 24 months]
- Immunogenicity [Time frame: Up to 24 months]
- Nectin-4 and PD-L1 expression [Time frame: Up to 24 months]
Eligibility criteria
Inclusion criteria
- Sign the informed consent form approved by IEC.
- Male or female subjects aged ≥18 years old.
- ECOG status: 0 or 1.
- Histologically confirmed urothelial cancer.
- Imaging confirmed non-metastatic urothelial cancer (M0). Arm 1: MIBC, T2-4aN0-1. Arm 2: High-risk UTUC, N0. Arm 3: MIBC, T2-4aN0.
- Adequate tumor tissues submitted for test.
- Life expectancy for more than 12 weeks.
- Adequate organ functions.
- Proper contraception methods.
- Willingness to follow the study procedures.
Exclusion criteria
- Prior systemic anti-tumor therapy for urothelial cancer.
- Previously treated with PD-1/PD-L1 inhibitors or antibody-drug conjugates (ADCs).
- 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 1 year.
- Major surgery treated within 28 days; Cystoscopy/ureteroscopy biopsy or intravesical instillation therapy within 7 days.
- Peripheral neuropathy Grade ≥ 2.
- Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc.
- Active HBV/HCV/HIV infection, etc.
- Any other serious chronic or uncontrolled disease.
- Any live vaccines got within 28 days.
- Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
- Any potent CYP3A4 inducers/inhibitors taken within 14 days.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07314723 · 9MW2821-CP202