Health TrialsbyHealthPanel

9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer

ConditionUrothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMabwell (Shanghai) Bioscience Co., Ltd.

About this trial

This is a single arm, open-label, multicenter phase II clinical study to evaluate the safety and efficacy of 9MW2821 combined with Toripalimab in perioperative patients with urothelial cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign the informed consent form approved by IEC.

Male or female subjects aged ≥18 years old.

ECOG status: 0 or 1.

Histologically confirmed urothelial cancer.

Disqualifiers

Prior systemic anti-tumor therapy for urothelial cancer.

Previously treated with PD-1/PD-L1 inhibitors or antibody-drug conjugates (ADCs).

History of another malignancy within 3 years.

History of autoimmune disease requiring systemic treatment within 2 years.

Trial design

Design model

Single group

Treatments tested in this trial

  • 9MW2821

    Drug

    9MW2821, 1.25mg/kg, intravenous (IV) infusion

  • Toripalimab Injection

    Drug

    Toripalimab, 240mg, intravenous (IV) infusion

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Arm 1: MIBCExperimental treatment 2 interventions
Group B: Arm 2: High-risk UTUCExperimental treatment 2 interventions
Group C: Arm 3: MIBCExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

pCR (Arm 1 and 2)

Pathological complete response

Time frame
Up to 24 months
2

cCR (Arm 3)

Clinical complete response

Time frame
Up to 24 months

Secondary outcomes

1

cORR

Clinical objective response rate

Time frame
Up to 24 months
2

Pathological downstaging rate (Arm 1 and 2)

Time frame
Up to 24 months
3

DFS (Arm 1 and 2)

Disease-free survival

Time frame
Up to 24 months
4

Duration of clinical complete response (Arm 3)

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mabwell (Shanghai) Bioscience Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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