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

NCT06405425 | Recruiting Phase 2

• 1 other identifier: BL-B01D1-204-03
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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).

  Up to approximately 24 months

Secondary Outcomes (8)

• 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

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Cmax

  Up to approximately 24 months

Study Arms (1)

BL-B01D1 + PD-1

EXPERIMENTAL

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.

Drug: BL-B01D1; Drug: PD-1

Interventions

BL-B01D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Also known as: iza-bren, izalontamab brengitecan, BMS-986507

BL-B01D1 + PD-1

PD-1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-B01D1 + PD-1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \&gt 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;
• History of ILD, current ILD, or suspected ILD;
• Complicated with pulmonary diseases leading to clinically severe respiratory impairment;
• Screening for unstable thrombotic events requiring therapeutic intervention within the preceding 6 months; Infusion-related thrombosis was excluded;
• Patients with active central nervous system metastases;
• Patients with massive or symptomatic effusions or poorly controlled effusions;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Dingwei Ye

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sa Xiao, PHD

CONTACT

+8615013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 8, 2024
• Study Start: May 29, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

CN (1)