A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 + PD-1 Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

• Unresectable locally advanced or metastatic urothelial carcinoma confirmed by histopathology and/or cytology;

• Participants should not have received previous systemic therapy for locally advanced or metastatic urothelial cancer;

• A biopsy sample of archived tumor tissue or metastatic urothelial carcinoma must be available within 3 years for PD-L1 and other testing;

• At least one measurable lesion meeting the RECIST v1.1 definition was required;

• The level of organ function must meet the requirements on the premise that blood transfusion and the use of any cell growth factors and/or platelet-raising drugs are not allowed within 14 days before the first dose;

⁃ Previous treatment-related toxicity returned to ≤ grade 1 defined by NCI-CTCAE v5.0;

⁃ For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Sa Xiao, PHD
xiaosa@baili-pharm.com
+8615013238943
Time Frame
Start Date: 2024-05-29
Estimated Completion Date: 2026-05
Participants
Target number of participants: 52
Treatments
Experimental: BL-B01D1 + PD-1
Participants receive BL-B01D1 + PD-1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Related Therapeutic Areas
Sponsors
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Leads: Sichuan Baili Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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