A Study of BL-B16D1 in Patients With Locally Advanced or Metastatic Solid Tumors

NCT ID: NCT06475131

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-18
• Study Completion Date: 2026-07-31

Brief Summary

This study is an open, multicenter, dose-escalation and expansion-enrollment and nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-B16D1 in locally advanced or metastatic solid tumors.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BL-B16D1

Participants receive BL-B16D1 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.

Group Type: EXPERIMENTAL

BL-B16D1

Intervention Type: DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Interventions

BL-B16D1

Administration by intravenous infusion for a cycle of 3 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Sign the informed consent form voluntarily and follow the protocol requirements;

2. Gender is not limited;

3. Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib);

4. Expected survival time ≥3 months;

5. locally advanced or metastatic solid tumors confirmed by histopathology and/or cytology that failed standard treatment or could not obtain standard treatment;

6. Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 3 years;

7. At least one measurable lesion meeting the RECIST v1.1 definition was required;

8. ECOG 0 or 1;

9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;

10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;

11. The organ function level must meet the requirements if the patient has not received blood transfusion or hematopoietic stimulating factor therapy within 14 days before screening;

12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5ULN;

13. Urinary protein ≤2+ or ≤1000mg/24h;

14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (male or female) should use adequate contraception throughout the treatment cycle and for 6 months after completion of treatment.

Exclusion Criteria

1. Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;

2. History of severe heart disease;

3. Long QT, complete left bundle branch block, III degree atrioventricular block;

4. Active autoimmune and inflammatory diseases;

5. Other malignancies diagnosed within 5 years before the first dose;

6. Hypertension poorly controlled by two antihypertensive drugs;

7. Patients with poor glycemic control;

8. Present with grade ≥2 radiation pneumonitis according to the RTOG/EORTC definition; Previous history of ILD or current ILD, or suspicion of such disease during screening;

9. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;

10. Active central nervous system metastasis;

11. Patients with a history of allergy to recombinant humanized or human-mouse chimeric antibodies or to any of the excipients of BL-B16D1;

12. Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);

13. The cumulative dose of anthracyclines > 360 mg/m2 in previous (new) adjuvant therapy;

14. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;

15. Severe infection occurred within 4 weeks before the first dose; Signs of pulmonary infection or active pulmonary inflammation within 2 weeks before the first dose;

16. Patients with massive or symptomatic effusions or poorly controlled effusions;

17. Had participated in another clinical trial within 4 weeks before the first dose;

18. Had the following ocular diseases: a. active infection or corneal ulcer; b. monocular vision; c. a history of corneal transplantation; d. Contact lens dependence; e. Uncontrolled glaucoma; f. Uncontrolled or progressive retinopathy, wet macular degeneration, etc.;

19. Other circumstances that the investigator deemed inappropriate for participation in the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Zhang

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

15013238943

Facility Contacts

Li Zhang

Role: primary

Other Identifiers

BL-B16D1-101

Identifier Type: -

Identifier Source: org_study_id