A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in Combination With Paclitaxel in the Treatment of Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

Sichuan Baili Pharmaceutical Co., Ltd.7 sites in 1 country42 target enrollmentDecember 22, 2021

ConditionsHead and Neck Squamous Cell Carcinoma

InterventionsSI-B001 Paclitaxel

Overview

Phase: Phase 2
Intervention: SI-B001
Conditions: Head and Neck Squamous Cell Carcinoma
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Enrollment: 42
Locations: 7
Primary Endpoint: ORR
Status: Active, not recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 22, 2021

End Date

December 1, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The participants could understand and sign the informed consent form and must participate voluntarily.
•No gender limit;
•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;
•Patients who failed or were intolerant to previous anti-PD-1 monoclonal antibody, platinum-containing chemotherapy or anti-PD-1 monoclonal antibody monotherapy Treatment failure of PD-1 refers to disease progression during or after PD-1 treatment;
•Failure of platinum-containing chemotherapy refers to:
•disease progression during or after platinum-containing chemotherapy;
•recurrence or disease progression within 6 months of platinum-containing multi-mode therapy;
•Previously received only ≤ 2-line treatment for recurrent and metastatic squamous cell carcinoma of the head and neck;
•Agree to provide tumor tissue samples (FFPE block or 10 unstained sections of 5μm size) or fresh tissue samples that have been archival within 1 year of primary or metastatic lesion. If the patient fails to provide them, they can be included after the investigator's judgment;

Exclusion Criteria

•Squamous cell carcinoma with primary site of nasopharynx or skin;
•Have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor therapy within 4 weeks prior to the first use of the study drug, except the following:
•Nitrosorea or mitomycin C within 6 weeks before the first administration of the study drug;
•Oral fluorouracil and small molecule targeted drugs are 2 weeks before the first administration of the study drug or within the 5 half-lives of the drug (whichever is longer);
•The traditional Chinese medicines with anti-tumor indications were within 2 weeks before the first use of the study drug;
•Received an unmarketed clinical investigational drug or treatment within 4 weeks prior to the first use of the investigational drug;
•Has undergone major organ surgery (excluding needle biopsy, tracheotomy, gastrostomy, etc.) or has significant trauma within 4 weeks before the first use of study drugs, or needs to undergo elective surgery during the trial;
•Patients with prior use of paclitaxel or albumin paclitaxel or paclitaxel liposome;
•Previous recipients of allogeneic hematopoietic stem cell transplantation or organ transplantation;
•A history of serious cardiovascular and cerebrovascular diseases, including but not limited to:

Arms & Interventions

SI-B001 combined with paclitaxel

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.

Intervention: SI-B001