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

NCT ID: NCT06079112

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-27
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Advanced Urothelial Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

9MW2821+Toripalimab

Group Type: EXPERIMENTAL

9MW2821

Intervention Type: DRUG

1.0/1.25/1.5 mg/kg, intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.

Toripalimab

Intervention Type: DRUG

240mg intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.

Interventions

9MW2821

1.0/1.25/1.5 mg/kg, intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.

Intervention Type: DRUG

Toripalimab

240mg intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.

Intervention Type: DRUG

Other Intervention Names

9MW2821 injection; Toripalimab injection

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mabwell (Shanghai) Bioscience Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Guo, Professor

Role: CONTACT

guoj307@126.com

010-88196358

Facility Contacts

Jun Guo, Professor

Role: primary

guoj307@126.com

010-88196358

Other Identifiers

9MW2821-2023-CP104

Identifier Type: -

Identifier Source: org_study_id