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

NCT06857175 | Recruiting Phase 3 DMC

• 1 other identifier: BL-B01D1-309
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS)

  Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

  Up to approximately 24 months

• Overall survival (OS)

  Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.

  Up to approximately 24 months

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  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

• Anti-drug antibody (ADA)

  Up to approximately 24 months

Study Arms (2)

BL-B01D1

EXPERIMENTAL

Participants receive BL-B01D1 in 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

Docetaxel or Paclitaxel

ACTIVE COMPARATOR

Participants receive Docetaxel or Paclitaxel in 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: Docetaxel or Paclitaxel

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

Docetaxel or Paclitaxel DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Docetaxel or Paclitaxel

Eligibility Criteria

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

You may qualify if:

• Sign the informed consent form voluntarily and follow the protocol requirements;
• Age: ≥18 years old;
• Expected survival time ≥3 months;
• Patients with unresectable locally advanced or metastatic urothelial carcinoma who had failed platinum-based chemotherapy and PD-1/PD-L1 inhibitors;
• Patients with locally advanced or metastatic urothelial carcinoma who are eligible for treatment with the control chemotherapy agents specified in this protocol;
• Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG 0 or 1;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• If blood transfusion and colony-stimulating factor were not allowed within 14 days before randomization, the organ function level had to meet the requirements;
• A serum pregnancy test must be performed within 7 days before the start of treatment for premenopausal women of childbearing potential, and the result must be negative and 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:

• Chemotherapy, targeted therapy, biological therapy, etc. were used within 4 weeks or 5 half-lives before randomization;
• Patients with locally advanced or metastatic urothelial carcinoma who were suitable for radical local therapy were excluded;
• Frontline received ADCs targeting topoisomerase I inhibitors or EGFR and/or HER3; The front line had received both paclitaxel and docetaxel;
• History of severe heart disease and cerebrovascular disease;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
• Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
• Diagnosed with active malignancy within 3 years before randomization;
• Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
• Patients with poor glycemic control;
• Patients with grade ≥1 radiation pneumonitis according to the RTOG/EORTC definition; Previous history of ILD, or suspicion of such disease during screening;
• Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
• Patients with active central nervous system metastases;
• Severe infection occurred within 4 weeks before randomization; Evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization;
• Patients with massive or symptomatic effusions or poorly controlled effusions;
• Imaging examination indicated that the tumor had invaded or wrapped around the large blood vessels of the abdomen, chest, neck, and pharynx, except for those that the investigator thought would not affect the patient's enrollment in the drug;

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

Interventions

Docetaxel; Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CN (1)