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

Sichuan Baili Pharmaceutical Co., Ltd.3 sites in 1 country11 target enrollmentOctober 20, 2021

ConditionsHead and Neck Squamous Cell Carcinoma

InterventionsSI-B001

DrugsSI-B001

Overview

Phase: Phase 2
Intervention: SI-B001
Conditions: Head and Neck Squamous Cell Carcinoma
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Enrollment: 11
Locations: 3
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 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.

Registry

clinicaltrials.gov

Start Date

October 20, 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

•Sign the informed consent voluntarily and comply with the requirements of the program;
•Age ≥18; Gender is not limited;
•Expected survival time ≥3 months;
•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 mab and platinum-containing chemotherapy
•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;
•Agree to provide tumor tissue samples (FFPE block or 10 unstained sections of 5μm size) or fresh tissue samples archiving within one year from primary or metastatic foci. If the patient fails to provide the samples, 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;
•Previous recipients of allogeneic hematopoietic stem cell transplantation or organ transplantation;
•A history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
•Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, grade iii atrioventricular block, etc.

Arms & Interventions

Study treatment

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.

Intervention: SI-B001