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

Advanced Urothelial Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06079112
• Other study ID #: 9MW2821-2023-CP104
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: October 10, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2023
• Source: Mabwell (Shanghai) Bioscience Co., Ltd.
• Contact: Jun Guo, Professor
• Phone: 010-88196358
• Email: guoj307[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Urothelial Carcinoma
• Carcinoma, Transitional Cell

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Mabwell (Shanghai) Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of AE/SAE	adverse event(AE) ?serious adverse event(SAE)	Up to 24 months
Secondary	Objective Response Rate, ORR	complete response (CR) or partial response (PR)	Up to 24 months
Secondary	Duration of Response, DOR	Time from the date of the first CR or PR to the earliest date of disease progression or death	Up to 24 months
Secondary	Time To Response, TTR	Time from the date of first infusion to the date of CR or PR	Up to 24 months
Secondary	Disease Control Rate, DCR	the percentage of subjects who experience CR, PR or stable disease (SD)	Up to 24 months
Secondary	Progression-Free Survival, PFS	Time from the date of first infusion to the earliest date of disease progression or death	Up to 24 months
Secondary	Overall Survival, OS	Time from the date of first infusion to the date of death	Up to 24 months
Secondary	Pharmacokinetics parameter	drug concentration of 9MW2821	Up to 12 months
Secondary	Immunogenicity parameter	Anti-Drug Antibody (ADA) of 9MW2821	Up to 12 months