A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Chordoma

NCT06787664 | Active Not Recruiting Phase 2

• 1 other identifier: BL-B01D1-209
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, multicenter phase II study to evaluate the safety, efficacy and pharmacokinetic characteristics of BL-B01D1 for Injection in patients with locally advanced or metastatic chordoma.

Conditions

Chordoma

Outcome Measures

Primary Outcomes (1)

• 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 (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

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

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

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;
• Locally advanced (unresectable) or metastatic chordoma confirmed by histopathology;
• ECOG ≤2;
• The expected survival time as judged by the investigator was ≥3 months;
• 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%;
• Organ function level must meet the requirements;
• Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;
• Urine protein ≤2+ or \< 1000mg/24h;
• For premenopausal women with childbearing potential, 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 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, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives before the first dose, small molecule targeted therapy within 5 days, and palliative radiotherapy within 2 weeks;
• A history of central nervous system hemorrhage/infarction requiring treatment within 6 months before enrollment;
• History of severe heart disease and cerebrovascular disease;
• QT prolongation, complete left bundle branch block, III degree atrioventricular block, severe arrhythmia;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
• Active autoimmune and inflammatory diseases;
• Other malignant tumors that progressed or required treatment within 5 years before the first dose;
• Poorly controlled hypertension (systolic blood pressure after adequate medical therapy \&gt; 150 mmHg or diastolic blood pressure \&gt; 100 mmHg);
• Poor glycemic control;
• Patients with a previous history of ILD requiring hormone therapy, or current ILD or ≥G2 radiation pneumonitis, or suspected to have such a condition during screening;
• Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
• Patients with a history of allergy to recombinant humanized or human-mouse chimeric antibodies or to any of the excipients of BL-B01D1;
• Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
• Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
• Had a serious infection within 4 weeks before the first dose of study drug; Indications of active pulmonary infection within 2 weeks before the first dose of study drug;

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Chordoma

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms

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: January 16, 2025
• First Posted: January 22, 2025
• Study Start: January 16, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (1)