Menu
Recruiting NCT06079112

9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer

Phase I / Phase II Interventional Advanced Urothelial Carcinoma

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.
Who it may be relevant to
Registry conditions: Advanced Urothelial Carcinoma. Basic parameters: 18 years — 80 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 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

Overview

This is a phase Ib/II, open-label, multicenter clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of 9MW2821 combined with Toripalimab injection in subjects with local advanced or metastatic urothelial cancer.

Interventions

  • Drug 9MW2821
    1.0/1.25/1.5 mg/kg, intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.
  • Drug Toripalimab
    240mg intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.

Primary outcome measures

  • incidence of AE/SAE [Time frame: Up to 24 months]
Secondary outcome measures (8)
  • Objective Response Rate, ORR [Time frame: Up to 24 months]
  • Duration of Response, DOR [Time frame: Up to 24 months]
  • Time To Response, TTR [Time frame: Up to 24 months]
  • Disease Control Rate, DCR [Time frame: Up to 24 months]
  • Progression-Free Survival, PFS [Time frame: Up to 24 months]
  • Overall Survival, OS [Time frame: Up to 24 months]
  • Pharmacokinetics parameter [Time frame: Up to 12 months]
  • Immunogenicity parameter [Time frame: Up to 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT06079112 · 9MW2821-2023-CP104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗