RecruitingPhase 2NCT06475300

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal 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 Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

570 participants

Start Date

Jun 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 Monoclonal Antibody in patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma and other solid tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — BL-B01D1 (an antibody-drug conjugate that delivers chemotherapy directly to cancer cells) and a PD-1 immune checkpoint inhibitor — in people with advanced non-small cell lung cancer or nasopharyngeal carcinoma (cancer in the back of the nose/throat) that has not responded to previous treatment. **You may be eligible if...** - You are 18 years old or older - You have advanced non-small cell lung cancer or nasopharyngeal carcinoma confirmed by biopsy - Your cancer has at least one measurable area - You are generally in good health and able to carry out daily activities (ECOG 0 or 1) - Your blood counts, heart, liver, and kidneys are functioning adequately **You may NOT be eligible if...** - You have uncontrolled heart arrhythmia or heart ejection fraction below 50% - You have active autoimmune disease or a history of organ transplant - You have HIV, active Hepatitis B or C, or active tuberculosis - You have received another cancer drug or clinical trial treatment within 4 weeks - 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)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06475300


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