RecruitingPhase 2NCT06437522

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

A Phase II Clinical Trial To Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma) and Other Solid Tumors


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

46 participants

Start Date

Jun 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid tumors.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests BL-B01D1 (a targeted antibody-drug conjugate) combined with a PD-1 immunotherapy drug in patients with head and neck squamous cell carcinoma that has returned or spread, as well as other solid tumors. The treatment aims to use the immune system alongside a targeted chemo payload to fight the cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have recurrent or metastatic head and neck squamous cell carcinoma (not nasopharyngeal cancer) or another eligible solid tumor, confirmed by biopsy - You have at least one measurable tumor - You have not previously received systemic treatment for your recurrent or metastatic disease - Your expected survival is at least 3 months - You are in good general health (ECOG score 0–1) **You may NOT be eligible if...** - You have previously received a topoisomerase I inhibitor-based ADC drug - You previously had a severe immune-related reaction (grade 3 or higher) from immunotherapy - You are on systemic corticosteroids or immunomodulatory drugs - 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-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGPD-1 monoclonal antibody

Administration by intravenous infusion for a cycle of 3 weeks.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06437522


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