A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors

NCT05785039 | Recruiting Phase 2

• 1 other identifier: BL-B01D1-201
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Phase IIa/IIb clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors such as locally advanced or metastatic urinary system tumors.

Conditions

Urinary System Tumor; Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Phase IIa: Recommended Phase II Dose (RP2D)

  The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1.

  Up to approximately 24 months

• Phase IIb: Objective response rate (ORR)

  ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

  Up to approximately 24 months

Secondary Outcomes (12)

• Phase IIa/IIb: Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Phase IIa: Objective response rate (ORR)

  Up to approximately 24 months

• Phase IIb: Progression-free survival (PFS)

  Up to approximately 24 months

• Phase IIa/IIb: Disease control rate (DCR)

  Up to approximately 24 months

• Phase IIa/IIb: Duration of response (DOR)

  Up to approximately 24 months

Study Arms (1)

Study treatment

EXPERIMENTAL

Participants receive BL-B01D1 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

Interventions

BL-B01D1 DRUG

Administration by intravenous infusion

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

Study treatment

Eligibility Criteria

• Age: 18 Years - 75 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;
• Gender is not limited;
• Age: ≥18 years old and ≤75 years old;
• Expected survival time ≥3 months;
• Locally advanced or metastatic urothelial carcinoma and other solid tumors confirmed by histopathology and/or cytology after failure or intolerance to standard treatment or for which standard treatment is currently unavailable or unavailable;
• Testosterone levels in prostate cancer \< 1.73 nmol/L (50 ng/dL), disease progression before screening, according to the PCWG3 consensus;

You may not qualify if:

• At least one measurable lesion (other than prostate cancer), as defined by RECIST v1.1, was required;
• ECOG 0 or 1;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• With adequate organ function;
• For premenopausal women who are likely to have children, a pregnancy test must be performed within 7 days before starting treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.
• Antineoplastic therapy within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral fluorouracil drugs;
• History of severe cardiovascular and cerebrovascular diseases;
• Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
• Active autoimmune and inflammatory diseases;
• Other malignant tumors that progressed or required treatment within 5 years before the first dose;
• Patients with poor blood glucose control before the first dose;
• Hypertension poorly controlled with two antihypertensive drugs before the first dose or previous history of hypertensive crisis or hypertensive encephalopathy;
• A history of interstitial lung disease (ILD), current ILD, or suspicion of such disease on imaging during screening;
• Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;

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, 200032, China

RECRUITING

MeSH Terms

Conditions

Urologic Neoplasms

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Study Officials

• Dingwei Ye, PHD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sa Xiao, PHD

CONTACT

+86-15013238943; 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: March 9, 2023
• First Posted: March 27, 2023
• Study Start: April 20, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

CN (1)