A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byYe Guo

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This multi-center, open label phase II clinical study is performed in patients with recurrent metastatic squamous cell carcinoma of the head and neck progressed on prior anti-PD-1 mab ± platinum-based chemotherapy. This study is investigating the safety and efficacy of SI-B001 as a single agent in patients.

Research Team

Ye Guo

Principal Investigator

Shanghai Oriental Hospital

Eligibility Criteria

Inclusion Criteria

Sign the informed consent voluntarily and comply with the requirements of the program;

Age ≥18; Gender is not limited;

Expected survival time ≥3 months;

See 7 more

Treatment Details

Interventions

SI-B001 (PD-L1 Inhibitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Study treatmentExperimental Treatment1 Intervention

SI-B001 is a bispecific antibody targeting EGFR and HER3, which is administered weekly by intravenous infusion（QW）. The 4-week cycle was maintained until disease progression or cessation due to intolerable toxicity or other reasons (e.g., withdrawal of informed consent or death). From C1D1, efficacy was evaluated every 8 weeks ±7 days in the first year and every 12 weeks ±7 days in the second year.