NCT06405425
Recruiting
Phase 2
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
ConditionsUrothelial Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- BL-B01D1
- Conditions
- Urothelial Carcinoma
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR)
- Status
- Recruiting
- Last Updated
- 12 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
- •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.
Exclusion Criteria
- •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;
- •The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;
- •QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- •Active autoimmune and inflammatory diseases;
- •Receiving \> before the first dose; Long-term systemic corticosteroid therapy with prednisone 10mg/d;
- •Other malignant tumors that progressed or required treatment within 5 years before the first dose;
- •Presence of: a) poorly controlled diabetes mellitus before starting study treatment; b) severe complications associated with diabetes mellitus; c) a glycated hemoglobin level of 8% or more; d) hypertension poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy;
Arms & Interventions
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.
Intervention: BL-B01D1
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.
Intervention: PD-1
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: Up to approximately 24 months
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Secondary Outcomes
- Cmax(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Tmax(Up to approximately 24 months)
- Ctrough(Up to approximately 24 months)
- Anti-drug antibody (ADA)(Up to approximately 24 months)
- Progression-free survival (PFS)(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)
Study Sites (1)
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