Evaluating BL-B16D1 for patients with advanced head and neck cancers and other solid tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

This study is testing a new treatment called BL-B16D1 to see if it can help people with advanced head and neck cancers and other solid tumors who haven't had success with other therapies.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06469008 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter phase I clinical trial designed to assess the safety, tolerability, pharmacokinetics, and preliminary effectiveness of a new treatment called BL-B16D1 in patients with recurrent or metastatic head and neck squamous cell carcinoma and other solid tumors. The study will involve increasing doses of the treatment to determine the optimal dosage and monitor any adverse effects. Participants must have previously failed standard treatments and provide tumor samples for analysis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with recurrent or metastatic head and neck squamous cell carcinoma or other solid tumors who have not responded to standard therapies.

Not a fit: Patients with severe cardiac dysfunction or those who have not recovered from the toxicity of previous cancer treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced cancers that have limited treatment alternatives.

How similar studies have performed: While this approach is novel, similar studies targeting advanced solid tumors have shown promise in the past, indicating potential for success.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Ye Guo — Shanghai East Hospital
• Study coordinator: Sa Xiao, PHD

Conditions: Head and Neck Squamous Cell Carcinomas, Solid Tumor