A Study of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

NCT ID: NCT06469008

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-27
• Study Completion Date: 2026-07-31

Brief Summary

This study is an open, multicenter, increasing dose and dose extension nonrandomized phase I clinical study to evaluate the safety, tolerance, pharmacokinetic characteristics and preliminary effectiveness of BL-B16D1 in recurrent or metastatic head and neck squamous cell carcinomas and other solid tumors.

Conditions

Head and Neck Squamous Cell Carcinomas; 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. Patients with pathologically and/or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma and other solid tumors who failed or could not receive standard treatment;

6. Agreed to provide primary tumors or metastases 3 years archive of tumor tissue samples or fresh tissue samples;

7. Must have at least one accord with RECIST v1.1 define measurable lesions;

8. ECOG physical status 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. Blood coagulation function: international standardization ratio (INR) 1.5 or less, and the part activated clotting time (APTT) live enzymes ULN 1.5 or less;

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 the patients (no matter male or female) shall be 6 months after the end of the treatment period and adequate precautions.

Exclusion Criteria

1. 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 drugs such as fluorouracil;

2. History of severe heart disease;

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

4. Active autoimmune and inflammatory diseases;

5. Before the first delivery within 5 years diagnosed as other malignant tumor;

6. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg);

7. Patients with poor glycemic control;

8. Present with grade ≥1 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. There is activity of the central nervous system symptoms;

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. Before transplant or allogeneic hematopoietic stem cell transplantation (Allo - HSCT);

13. Previous anthracycline-based adjuvant therapy (new), the cumulative dose anthracycline-based drugs > 360 mg/m2;

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 (calculated from the time of the last 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

Ye Guo

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital

Locations

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

15013238943

Facility Contacts

Ye Guo

Role: primary

Other Identifiers

BL-B16D1-102

Identifier Type: -

Identifier Source: org_study_id