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

Primary Purpose

Advanced Urothelial Carcinoma

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
9MW2821
Toripalimab
Sponsored by
Mabwell (Shanghai) Bioscience Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Urothelial Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

9MW2821+Toripalimab

Arm Description

Outcomes

Primary Outcome Measures

incidence of AE/SAE
adverse event(AE) 、serious adverse event(SAE)

Secondary Outcome Measures

Objective Response Rate, ORR
complete response (CR) or partial response (PR)
Duration of Response, DOR
Time from the date of the first CR or PR to the earliest date of disease progression or death
Time To Response, TTR
Time from the date of first infusion to the date of CR or PR
Disease Control Rate, DCR
the percentage of subjects who experience CR, PR or stable disease (SD)
Progression-Free Survival, PFS
Time from the date of first infusion to the earliest date of disease progression or death
Overall Survival, OS
Time from the date of first infusion to the date of death
Pharmacokinetics parameter
drug concentration of 9MW2821
Immunogenicity parameter
Anti-Drug Antibody (ADA) of 9MW2821

Full Information

First Posted
September 25, 2023
Last Updated
October 9, 2023
Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06079112
Brief Title
9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 10, 2023 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Urothelial Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
9MW2821+Toripalimab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
9MW2821
Other Intervention Name(s)
9MW2821 injection
Intervention Description
1.0/1.25/1.5 mg/kg, intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.
Intervention Type
Drug
Intervention Name(s)
Toripalimab
Other Intervention Name(s)
Toripalimab injection
Intervention Description
240mg intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.
Primary Outcome Measure Information:
Title
incidence of AE/SAE
Description
adverse event(AE) 、serious adverse event(SAE)
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Objective Response Rate, ORR
Description
complete response (CR) or partial response (PR)
Time Frame
Up to 24 months
Title
Duration of Response, DOR
Description
Time from the date of the first CR or PR to the earliest date of disease progression or death
Time Frame
Up to 24 months
Title
Time To Response, TTR
Description
Time from the date of first infusion to the date of CR or PR
Time Frame
Up to 24 months
Title
Disease Control Rate, DCR
Description
the percentage of subjects who experience CR, PR or stable disease (SD)
Time Frame
Up to 24 months
Title
Progression-Free Survival, PFS
Description
Time from the date of first infusion to the earliest date of disease progression or death
Time Frame
Up to 24 months
Title
Overall Survival, OS
Description
Time from the date of first infusion to the date of death
Time Frame
Up to 24 months
Title
Pharmacokinetics parameter
Description
drug concentration of 9MW2821
Time Frame
Up to 12 months
Title
Immunogenicity parameter
Description
Anti-Drug Antibody (ADA) of 9MW2821
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Guo, Professor
Phone
010-88196358
Email
guoj307@126.com
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Guo, Professor
Phone
010-88196358
Email
guoj307@126.com

12. IPD Sharing Statement

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

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