Combining 9MW2821 and Toripalimab for advanced urothelial cancer

A Phase Ib/II, Open-label, Single Arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer

This study is testing if a new combination of two drugs, 9MW2821 and Toripalimab, can help people with advanced bladder cancer feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, Toripalimab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06079112 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of 9MW2821 in combination with Toripalimab in patients with local advanced or metastatic urothelial cancer. It is an open-label, multicenter study that aims to assess various factors including pharmacokinetics and immunogenicity. Participants will be monitored for their response to the treatment and any potential side effects. The study includes patients who have previously received standard therapy or have not been treated before.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with confirmed local advanced or metastatic urothelial cancer who have received at least one line of standard therapy.

Not a fit: Patients who have undergone recent anti-tumor treatments or major surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced urothelial cancer.

How similar studies have performed: While this approach is novel, similar combinations of immunotherapy and targeted therapy have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

* Sign and date the informed consent form e approved by independent ethics committe.
* Male or female subjects aged 18 to 80 years (including 18 and 80 years).
* ECOG status of 0 or 1.
* Histologically or cytologically confirmed local advanced or metastatic urothelial cancer
* Subjects have received at least 1 line advanced standard therapy or were not treated before
* Subjects must submit tumor tissues for test
* Life expectancy of ≥ 12 weeks.
* Subjects must have measurable lesions according to RECIST (version 1.1).
* Adequate organ functions
* Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
* Subjects are willing to follow study procedures.

Exclusion Criteria:

* Anti-tumor treatment such as chemotherapy and radiotherapy within 21 days prior to the first dose of study drug.
* Major surgery within 28 days prior to first dose of study drug.
* PD-1/PD-L1/PD-L2 inhibitors used in the previous treatment for La/m UC.
* Previous treatment with ADCs conjugated with MMAE payload.
* Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.
* Peripheral neuropathy Grade ≥ 2.
* Poorly controlled blood sugar.
* Increased risks of corneal disease assessed by the investigator prior to the first dose of study drug.
* Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
* Active infections, such as uncontrolled HBV/HCV/HIV/TB infection, etc.
* Other serious or uncontrolled diseases, such as serious interstitial pneumonia/asthma, serious thromboembolic events, etc.
* Poorly controlled central nervous system metastases.
* Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
* History of drug abuse or mental illness.
* Known allergic sensitivity to any of the ingredients of the study drug.
* Any P-glycoprotein (P-gp) inducers/inhibitors or potent CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug.
* History of autoimmune disease requiring systemic treatment within 2 years before the first dose.
* Any live vaccines within 4 weeks before first dose of study drug or during the study.
* Use of any investigational drug or medical instruments within 28 days prior to the first dose of study drug.
* History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.
* Other conditions unsuitable into the study.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jun Guo, Professor

Conditions Advanced Urothelial Carcinoma