RecruitingPhase 1NCT06469008

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


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

21 participants

Start Date

Jun 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new drug called BL-B16D1 in people with head and neck squamous cell carcinoma or other solid tumors that have come back or spread after standard treatments have stopped working. **You may be eligible if...** - You are 18 to 75 years old (Phase Ia) or 18 and older (Phase Ib) - You have confirmed recurrent or metastatic head and neck squamous cell carcinoma or another solid tumor - You have already tried standard treatments and they no longer work - You have at least one measurable tumor on a scan - Your ECOG performance score is 0 or 1 (fully active or restricted only in strenuous activity) - Your expected survival is at least 3 months **You may NOT be eligible if...** - Your overall health status is too poor for trial participation - You have serious heart, liver, or kidney problems - Previous treatment side effects have not resolved - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBL-B16D1

Administration by intravenous infusion for a cycle of 3 weeks.


Locations(1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

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NCT06469008


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