All subjects will receive a single intravenous (IV) infusion of 9MW2821 once weekly for the first 3 weeks of every 4 week cycle (i.e., on Days 1, 8 and 15).

9MW2821

Jun Guo, Professor

This study is a Phase 1, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion.

A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors

A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of 9MW2821 in Advanced Malignant Solid Tumors

Area under the concentration-time curve (AUC)

Mabwell (Shanghai) Bioscience Co., Ltd.

Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

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

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

Toripalimab

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.

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

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

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

complete response (CR) or partial response (PR)

Time from the date of the first CR or PR to the earliest date of disease progression or death

Time from the date of first infusion to the date of CR or PR

the percentage of subjects who experience CR, PR or stable disease (SD)

Time from the date of first infusion to the earliest date of disease progression or death

Time from the date of first infusion to the date of death

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

1.25mg/kg of 9MW2821 by intravenous infusion on days 1, 8 and 15 of every 28-day cycle

75mg/m\^2 docetaxel by intravenous infusion or 175 mg/m\^2 paclitaxel by intravenous infusion on day 1 of every 21-day cycle.

Chemotherapy

Dingwei Ye, Professor

Ding Ye, Professor

The purpose of this study was to compare the antitumor activity of 9MW2821 and chemotherapy in participants with locally advanced or metastatic urothelial cancer previously treated with PD-(L)1 inhibitor and platinum-containing chemotherapy.

A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer

An Open-label, Randomized Phase 3 Study to Evaluate 9MW2821 vs Investigator's Choice of Chemotherapy in Subjects With Locally Advanced or Metastatic Urothelial Cancer Who Have Previously Received PD-(L)1 Inhibitor and Platinum-containing Chemotherapy

Time from the date of first randomization to the earliest date of documented disease progression per radiological evidence or death from any cause

Time from the date of randomization until the date of death from any cause

The percentage of subjects who experience a best response of either CR or PR

Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause

Time from the date of randomization to the date of confirmed CR or PR

Defined as the percentage of subjects who experience a best response of CR, PR or stable disease (SD)

Jian Zhang, Professor

This study is a Phase 1/2, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion.

A Clinical Study of 9MW2821 in Subjects With Advanced Malignant Solid Tumors

Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of 9MW2821 in Subjects With Advanced Malignant Solid Tumors

Defined as the percentage of subjects who experience a best response of either CR or PR. CR and PR must be confirmed ≥ 28 days later.

Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause. DOR is only defined for subjects who have best overall response of CR or PR.

Time from the date of first infusion to the date of confirmed CR or PR

Time from the date of first infusion to the earliest date of documented disease progression per radiological evidence or death from any cause

Time from the date of first infusion until the date of death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors	NCT05773937	Advanced Malign...	9MW2821	18 Years - 80 Years	Mabwell (Shanghai) Bioscience Co., Ltd.
9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer	NCT06079112	Advanced Urothe...	9MW2821 Toripalimab	18 Years - 80 Years	Mabwell (Shanghai) Bioscience Co., Ltd.
A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer	NCT06196736	Advanced Urothe...	9MW2821 Chemotherapy	18 Years - 75 Years	Mabwell (Shanghai) Bioscience Co., Ltd.
A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer	NCT06196736	Advanced Urothe...	9MW2821 Chemotherapy	18 Years - 75 Years	Mabwell (Shanghai) Bioscience Co., Ltd.
A Clinical Study of 9MW2821 in Subjects With Advanced Malignant Solid Tumors	NCT05216965	Solid Tumors	9MW2821	18 Years - 80 Years	Mabwell (Shanghai) Bioscience Co., Ltd.

Spots Global Cancer Trial Database for 9mw2821

Every month we try and update this database with for 9mw2821 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for 9mw2821

Every month we try and update this database with for 9mw2821 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for 9mw2821 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.