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

Mabwell Bioscience

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Advanced Urothelial Carcinoma

Treatments

Drug: Toripalimab

Drug: 9MW2821

Study type

Interventional

Funder types

Industry

Identifiers

NCT06079112

9MW2821-2023-CP104

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.