A Phase Ill Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice as Second Line Treatment in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma After Failure of PD-1/PD-L1 Monoclonal Antibody in Combination With Platinum-based Chemotherapy
Overview
- Phase
- Phase 3
- Intervention
- BL-B01D1
- Conditions
- Esophageal Squamous Cell Carcinoma
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Enrollment
- 497
- Locations
- 1
- Primary Endpoint
- Overall survival (OS)
- Status
- Active, not recruiting
- Last Updated
- 15 days ago
Overview
Brief Summary
This study is a registered phase Ill, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic esophageal squamous cell carcinoma after failure of PD-1/PD-L1 monoclonal antibody in combination with platinum-based chemotherapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntarily sign the informed consent and follow the requirements of the protocol;
- •Age ≥18 years old;
- •Expected survival time ≥3 months;
- •Patients with recurrent or metastatic esophageal squamous cell carcinoma confirmed by histology or cytology;
- •Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
- •Must have at least one measurable lesion according to RECIST v1.1 definition;
- •ECOG 0 or 1;
- •Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
- •No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- •No blood transfusion and no use of any cell growth factor drugs were allowed within 14 days before randomization, and the level of organ function had to be adequate;
Exclusion Criteria
- •Chemotherapy, targeted therapy, biological therapy, etc., had been used within 4 weeks or 5 half-lives before randomization, and palliative radiotherapy and modern traditional Chinese medicine preparations approved by NMPA had been used within 2 weeks;
- •Patients with recurrent esophageal squamous cell carcinoma suitable for radical local treatment should be excluded;
- •Frontline received ADCs with topoisomerase I inhibitors as toxins;
- •History of severe heart disease and cerebrovascular disease;
- •Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- •diagnosed with active malignancy within 3 years before randomization;
- •Hypertension poorly controlled by two antihypertensive drugs;
- •patients with poor glycemic control;
- •present with grade ≥1 radiation pneumonitis according to the RTOG/EORTC definition; A previous history of interstitial lung disease (ILD) or a suspicion of such disease on imaging during screening;
- •Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
Arms & Interventions
Experimental Group
Participants receive BL-B01D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Intervention: BL-B01D1
Control group
Participants receive Irinotecan or paclitaxel or docetaxel in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Intervention: Irinotecan
Control group
Participants receive Irinotecan or paclitaxel or docetaxel in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Intervention: paclitaxel
Control group
Participants receive Irinotecan or paclitaxel or docetaxel in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Intervention: docetaxel
Outcomes
Primary Outcomes
Overall survival (OS)
Time Frame: Up to approximately 24 months
Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.
Progression-free survival (PFS)
Time Frame: Up to approximately 24 months
Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Secondary Outcomes
- Objective Response Rate (ORR)(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Anti-drug antibody (ADA)(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)
- Cmax(Up to approximately 24 months)
- T1/2(Up to approximately 24 months)