Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 Combined With Irinotecan in the Treatment of Recurrent and Metastatic Esophageal Squamous Cell Carcinoma

Sichuan Baili Pharmaceutical Co., Ltd.6 sites in 1 country22 target enrollmentDecember 13, 2021

ConditionsEsophageal Squamous Cell Carcinomas

InterventionsSI-B001 Irinotecan

DrugsSI-B001 Irinotecan

Overview

Phase: Phase 2
Intervention: SI-B001
Conditions: Esophageal Squamous Cell Carcinomas
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Enrollment: 22
Locations: 6
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 and metastatic esophageal squamous cell carcinoma progressed on prior PD-1/L1 antibody with or without chemotherapy. This study is investigating the safety and efficacy of SI-B001 at optimal combination dose with irinotecan in patients.

Registry

clinicaltrials.gov

Start Date

December 13, 2021

End Date

December 1, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily sign the informed consent and follow the requirements of the protocol;
•Male or female, age: ≥18 years and ≤75 years;
•Expected survival time ≥3 months;
•Locally advanced esophageal squamous cell carcinoma confirmed histologically or pathologically as recurrent or metastatic or without indications of radical local treatment;
•Patients who failed or were intolerant to first-line anti-PD-1 (L1) monoclonal antibody plus platinum-based chemotherapy
•Agree to provide archived tumor tissue specimens of primary or metastatic lesion (4 surgical specimens (thickness 5μm) without staining section (anti-removal);6 unstained sections (anti-removal) surgical specimens (thickness 10μm) or fresh tissue samples, if the patient cannot provide, can be included after the investigator's judgment;
•There must be at least one measurable lesion conforming to the RECIST V1.1 definition. Tumor lesion located in the area of previous radiotherapy or other local and regional treatment sites is generally not a measurable lesion unless there is definite progression of the lesion or the lesion persists three months after radiotherapy;
•Physical fitness ECOG score of 0 or 1;
•Toxicity from previous antitumor therapy has returned to ≤1 as defined by NCI-CTCAE V5.0 (except for toxicity that the investigators determined to be of no safety risk, such as hair loss, grade 2 peripheral neurotoxicity, and stabilized hypothyroidism after hormone replacement therapy);
•Organ function levels must meet the following requirements and meet the following standards:

Exclusion Criteria

•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 for the following:
•Oral fluorouracil and small molecule targeted drugs were used within 2 weeks before the first administration of the study drug or within 5 half-lives of the drug; The traditional Chinese medicines with anti-tumor indications were within 2 weeks before the first use of the study drug;
•Patients with esophageal fistula;
•Received an unmarketed clinical investigational drug or treatment within 4 weeks prior to initial use of the investigational drug;
•Had major organ surgery (excluding needle biopsy, tracheotomy, gastrostomy, etc.) or had significant trauma within 4 weeks prior to the first use of study drugs, or needed to undergo elective surgery during the trial;
•Previous 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； In the resting state, QT interval was prolonged (QTc \> 450 msec in men or QTc \> 470 msec in women)； Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or higher cardio-cerebrovascular events within 6 months prior to the first administration; New York Heart Association (NYHA) heart function grade ≥II heart failure;
•Active autoimmune and inflammatory diseases, such as systemic lupus erythematosus, inflammatory bowel disease, etc., except type I diabetes, hypothyroidism that can be controlled only with replacement therapy, and skin diseases that do not require systemic treatment;
•Patients with a history of other malignant tumors and signs of recurrence and metastasis within 1 year before the first administration;

Arms & Interventions

SI-B001 combined with irinotecan

Patients with recurrent metastatic esophageal squamous cell carcinoma who had failed first-line therapy with PD-1(L1) monoclonal antibody plus platinum-based chemotherapy were enrolled.

Intervention: SI-B001

SI-B001 combined with irinotecan

Patients with recurrent metastatic esophageal squamous cell carcinoma who had failed first-line therapy with PD-1(L1) monoclonal antibody plus platinum-based chemotherapy were enrolled.

Intervention: Irinotecan