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

NCT06079112 | Recruiting Phase 1 DMC

• 1 other identifier: 9MW2821-2023-CP104
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• incidence of AE/SAE

  adverse event(AE) 、serious adverse event(SAE)

  Up to 24 months

Secondary Outcomes (8)

• Objective Response Rate, ORR

  Up to 24 months

• Duration of Response, DOR

  Up to 24 months

• Time To Response, TTR

  Up to 24 months

• Disease Control Rate, DCR

  Up to 24 months

• Progression-Free Survival, PFS

  Up to 24 months

Study Arms (1)

9MW2821+Toripalimab

EXPERIMENTAL

Drug: 9MW2821; Drug: Toripalimab

Interventions

9MW2821 DRUG

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

Also known as: 9MW2821 injection

9MW2821+Toripalimab

Toripalimab DRUG

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

Also known as: Toripalimab injection

9MW2821+Toripalimab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

toripalimab

Central Study Contacts

Jun Guo, Professor

CONTACT

010-88196358; guoj307@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 12, 2023
• Study Start: September 27, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 19, 2024

Record last verified: 2023-10

Locations

CN (1)