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Trial Title:
A Study of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
NCT ID:
NCT06469008
Condition:
Head and Neck Squamous Cell Carcinomas
Solid Tumor
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BL-B16D1
Description:
Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label:
BL-B16D1
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Ye Guo
Start date:
June 27, 2024
Completion date:
July 2026
Lead sponsor:
Agency:
Sichuan Baili Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Baili Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06469008
