RecruitingPhase 2NCT06006169

A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 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 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

186 participants

Start Date

Oct 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II study is designed to investigate the efficacy and safety of BL-B01D1 monotherapy, SI-B003 monotherapy, and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma and other solid tumors.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing new drug combinations — including BL-B01D1 (an antibody-drug conjugate) and SI-B003 (an anti-PD-L1 antibody) — in patients with head and neck squamous cell carcinoma or other solid tumors that have returned or spread and no longer respond to standard treatments. **You may be eligible if:** - You are between 18 and 75 years old - You have confirmed recurrent or metastatic head and neck squamous cell carcinoma (not nasopharyngeal) - Your cancer has progressed after at least one prior treatment, or you have not previously received systemic treatment in the metastatic setting (depending on which group you join) - You have at least one measurable tumor on imaging - You are in good general health (ECOG 0–1) **You may NOT be eligible if:** - You had certain cancer treatments within the past 4 weeks - You have an active, uncontrolled infection - You are pregnant or nursing - Your organ function does not meet the required levels 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBL-B01D1

BL-B01D1 was administered by intravenous infusion on D1, D8, or D1 in 3-week cycles.

DRUGSI-B003

SI-B003 was administered intravenously every 3 weeks (Q3W).


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06006169


Related Trials