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New treatment option for Head and Neck Squamous Cell Carcinomas
Official title A Study of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
ClinicalTrials.gov ID: NCT06469008
What this study is testing
What is BL-B16D1?
BL-B16D1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for head and neck squamous cell carcinomas.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Sign the informed consent form voluntarily and follow the protocol requirements;
- Gender is not limited;
- Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib);
- Expected survival time ≥3 months;
- Patients with pathologically and/or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma and other solid tumors who...
You likely can't join if
- Antineoplastic therapy within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the...
- History of severe heart disease;
- QT prolongation, complete left bundle branch block, III degree atrioventricular block;
- Active autoimmune and inflammatory diseases;
- Before the first delivery within 5 years diagnosed as other malignant tumor;
- Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
See the full eligibility criteria
- Sign the informed consent form voluntarily and follow the protocol requirements;
- Gender is not limited;
- Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib);
- Expected survival time ≥3 months;
- 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;
- Agreed to provide primary tumors or metastases 3 years archive of tumor tissue samples or fresh tissue samples;
- Must have at least one accord with RECIST v1.1 define measurable lesions;
- ECOG physical status 0 or 1;
- 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%;
- 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;
- 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;
- Urinary protein ≤2+ or ≤1000mg/24h;
- 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...
- 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;
- History of severe heart disease;
- QT prolongation, complete left bundle branch block, III degree atrioventricular block;
- Active autoimmune and inflammatory diseases;
- Before the first delivery within 5 years diagnosed as other malignant tumor;
- Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
- Patients with poor glycemic control;
- 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;
- Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
- There is activity of the central nervous system symptoms;
- Patients with a history of allergy to recombinant humanized or human-mouse chimeric antibodies or to any of the excipients of BL-B16D1;
- Before transplant or allogeneic hematopoietic stem cell transplantation (Allo - HSCT);
- Previous anthracycline-based adjuvant therapy (new), the cumulative dose anthracycline-based drugs \> 360 mg/m2;
- Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
- 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;
- Patients with massive or symptomatic effusions or poorly controlled effusions;
- Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose);
- 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...
- Other circumstances that the investigator deemed inappropriate for participation in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.