Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06079112
Other study ID # 9MW2821-2023-CP104
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04603846 - A Study of Anti-PD-L1 Antibody ZKAB001 Combined With Albumin-bound Paclitaxel in Advanced Urothelial Carcinoma Phase 1
Active, not recruiting NCT00365157 - Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction Phase 1/Phase 2
Recruiting NCT01487915 - Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma Phase 2
Not yet recruiting NCT04064190 - Vactosertib With Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition Phase 2
Recruiting NCT05544552 - Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations Phase 1/Phase 2
Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Active, not recruiting NCT02735252 - PROMOTE: Identifying Predictive Markers of Response for Genitourinary Cancer N/A
Recruiting NCT05733000 - CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors Phase 2
Recruiting NCT05738161 - Magrolimab in Combination With Cytotoxic Chemotherapy in Advanced Urothelial Carcinoma Phase 1
Completed NCT00942331 - Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer Phase 3
Not yet recruiting NCT05687721 - Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer Phase 1/Phase 2
Recruiting NCT04871334 - Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma Phase 1
Not yet recruiting NCT06196736 - A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer Phase 3
Completed NCT02599324 - Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors Phase 1/Phase 2
Active, not recruiting NCT04491942 - Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer Phase 1
Recruiting NCT05929235 - A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma Phase 1
Recruiting NCT04856189 - Selinexor and Pembrolizumab for the Treatment of Cisplatin-Ineligible or Cisplatin-Refractory Locally Advanced or Metastatic Urothelial Carcinoma Phase 1/Phase 2