9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma

Last updated: March 20, 2025
Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Urothelial Carcinoma

Bladder Cancer

Carcinoma

Treatment

9MW2821

Toripalimab (JS001 )

Clinical Study ID

NCT06823427
9MW2821-CP203
  • Ages 18-80
  • All Genders

Study Summary

This study will compare the efficacy of 9MW2821+toripalimab versus 9MW2821 monotherapy in locally advanced or metastatic urothelial carcinoma patients who have not received any systemic treatment in the metastatic or advanced setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Voluntary participation

  • Age 18-80

  • ECOG 0-1

  • Histologically confirmed inoperable locally advanced or metastatic urothelialcarcinoma (including bladder, renal pelvis and ureter). Mixed histology withsquamous or adenomatous differentiation is allowed if urothelial carcinomadifferentiation is >50%.

  • Has not received any systemic treatment for locally advanced or metastaticurothelial carcinoma

  • At least 1 measurable target lesion that satisfies RECIST v1.1 definition. If thepatient has received radiotherapy, the target lesion needs to be outside theradiation field or has demonstrated clear progression after radiotherapy.

  • Life expectancy over 12 weeks

  • Appropriate hematological and organ functions

  • Agree to contraceptive measures until 180 days after the last dose of study drugadministration

  • Able to understand and follow study visits, treatment, laboratory assessment andother procedures

Exclusion

Exclusion Criteria:

  • Other concurrent malignancy within 3 years prior to randomization

  • Active autoimmune disease requiring systemic treatment within 2 years prior torandomization. Having received high dose corticosteroid (>10mg/day prednisoloneequivalent) or other immunosuppressive agents.

  • Severe cardiovascular or cerebral vascular thrombo-embolic events within 6 monthsprior to randomization

  • Major surgery within 28 days prior to randomization, except for minor proceduresthat the PI considers not to impact study participation. Live vaccine within 28 daysprior to randomization or planning to take live vaccine during the study.Radiotherapy or bladder infusion therapy within 21 days prior to randomization. Useof strong CYP3A4 inhibitors within 14 days prior to randomization.

  • Lung effusion or ascites that require treatment within 14 days prior torandomization. Cancer-related severe uncontrolled bone pain or spinal cordcompression within 14 days prior to randomization. Active infection that requiressystemic antibiotic treatment within 7 days prior to randomization.

  • Have received prior treatment with anti-PD-1, anti-PD-L1/PD-L2 or anti-CTLA-4therapies. Have received prior treatment with Nectin-4 targeted therapy or ADC withMMAE as payload. Have received allogeneic hematological stem cell transplantation orsolid organ transplant.

  • Toxicities from previous cancer treatment (radiotherapy, chemotherapy or surgery)that have not recovered to grade 0-1 according to CTCAE v5.0, except for alopeciaand skin hyperpigmentation.

  • Severe dry eyes, active keratitis, corneal ulceration or other risk factors forcorneal diseases where the PI judges to be not suited for this study

  • Preexisting grade ≥ 2 neuropathy prior to randomization

  • Other uncontrolled serious illness

  • Brain metastasis or meningeal carcinomatosis

  • HBsAg positive, and HBV-DNA copy number positive ; HCV-Ab positive and HCV-RNApositive; HIV-Ab positive

  • Known allergy to the study drug or components of the study drug

  • Drug abuse or psychiatric disorder that would impact study compliance

  • Other circumstances that the PI judges to be not suitable for the study

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: 9MW2821
Phase: 2
Study Start date:
January 17, 2025
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Beijing Chao-yang Hospital, Capital Medical University

    Beijing, Beijing
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian
    China

    Site Not Available

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Site Not Available

  • Hunan Tumor Hospital

    Changsha, Hunan 410013
    China

    Active - Recruiting

  • Jiangsu People's Hospital

    Nanjing, Jiangsu
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210000
    China

    Active - Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shandong
    China

    Site Not Available

  • Shao Yi Fu Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

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