A Clinical Study of SI-B001 in Combination With Paclitaxel in the Treatment of Recurrent and Metastatic HNSCC

Recruiting in Palo Alto (17 mi)

+6 other locations

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 relapsed metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) progressed on prior 1st or 2nd line with anti-PD-1 mab ± platinum-based chemotherapy. This study is investigating the safety and efficacy of SI-B001 at optimal combination dose with paclitaxel in patients.

Research Team

Eligibility Criteria

Inclusion Criteria

The participants could understand and sign the informed consent form and must participate voluntarily.

Age: ≥18 years old

Locally advanced squamous cell carcinoma of the head and neck confirmed by histology or pathology as recurrent metastatic or without indications of radical local treatment;

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Treatment Details

Interventions

Paclitaxel (Microtubule Inhibitor)
SI-B001 (PD-L1 Inhibitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: SI-B001 combined with paclitaxelExperimental Treatment2 Interventions

SI-B001 in combination with paclitaxel for the treatment of recurrent metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) with disease progression or intolerance.； The patient had previously received anti-PD-1 mab ± platinum-based chemotherapy； Patients' previous treatment line should be ≤2L.

Paclitaxel is already approved in Canada for the following indications: