A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 combination therapy in patients with locally advanced or metastatic urothelial carcinoma.

Eligibility criteria

Qualifiers

All subjects voluntarily participated in the study and signed informed consent;

Male or female aged ≥18 years and ≤75 years;

Expected survival time ≥3 months;

ECOG 0-1;

Disqualifiers

Prior ADC recipients with TOPI inhibitors as toxin;

Palliative radiotherapy within 2 weeks before the first dose;

Prior immunotherapy with grade ≥3 irAE or grade ≥2 immune-related myocarditis;

Use of an immunomodulatory drug within 14 days before the first dose of study drug;

Trial design

Treatments tested in this trial

  • BL-B01D1
  • PD-1

Treatment groups

52 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator