A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma(PANKU-Bladder01)

Recruiting Phase 3 Interventional Study
Urothelial Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
508 (estimated)
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd. · Industry
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About This Trial

This trial is a registered phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic urothelial carcinoma after failure of PD-1/PD-L1 monoclonal antibody and platinum-based chemotherapy.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Sign the informed consent form voluntarily and follow the protocol requirements; 2. Age: ≥18 years old; 3. Expected survival time ≥3 months; 4. Patients with unresectable locally advanced or metastatic urothelial carcinoma who had failed platinum-based chemotherapy and PD-1/P…
Contacts

Sa Xiao, PHD

15013238943

xiaosa@baili-pharm.com

CONTACT