A Phase III Randomized Controlled Trial to Compare BL-B01D1 With Physician's Choice of Chemotherapy (Last Line) in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Previously Treated With PD-1/PD-L1 Monoclonal Antibody and at Least Two Lines of Chemotherapy (at Least One Line of Platinum-based Chemotherapy)
Overview
- Phase
- Phase 3
- Intervention
- capecitabine
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Enrollment
- 386
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR)
- Status
- Active, not recruiting
- Last Updated
- 15 days ago
Overview
Brief Summary
A phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic nasopharyngeal carcinoma who had failed at least two lines of platinum-based chemotherapy after receiving PD-1/PD-L1 monoclonal antibody as the last line of therapy.
Detailed Description
Primary objective: To evaluate BICR-based objective response rate (ORR) and overall survival (OS) benefit of BL-B01D1 versus physician's choice of chemotherapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntarily sign the informed consent form and comply with the protocol requirements;
- •Age ≥18 years and ≤75 years;
- •Expected survival time ≥3 months;
- •Patients with recurrent or metastatic nasopharyngeal carcinoma confirmed by histology or cytology, who have failed treatment with PD-1/PD-L1 monoclonal antibodies and at least two lines of chemotherapy (including at least one platinum-based regimen);
- •Patients with recurrent or metastatic nasopharyngeal carcinoma suitable for receiving the control group chemotherapy drugs specified in this protocol as the last-line treatment;
- •Must have at least one measurable lesion as defined by RECIST v1.1;
- •ECOG performance status score of 0 or 1;
- •Toxicity from prior anti-tumor treatment has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- •No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
- •Organ function levels must meet the requirements without transfusion, use of any cell growth factors, and/or platelet-raising drugs within 14 days before randomization;
Exclusion Criteria
- •Use of chemotherapy, targeted therapy, biologic therapy, etc., within 4 weeks or 5 half-lives before randomization, or palliative radiotherapy and antitumor therapy within 2 weeks;
- •Patients with recurrent nasopharyngeal carcinoma suitable for curative-intent local treatment (surgery or radiotherapy) should be excluded;
- •Prior treatment with ADC drugs containing topoisomerase I inhibitor as the small-molecule toxin, or ADC drugs targeting EGFR and/or HER3;
- •History of severe cardiac disease;
- •Unstable thrombotic events requiring therapeutic intervention within 6 months before screening (except for catheter-related thrombosis lasting \>4 weeks);
- •QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
- •Diagnosis of active malignancy within 3 years before randomization;
- •Poorly controlled hypertension despite two antihypertensive medications, or poorly controlled diabetes, or presence of diabetic gangrene;
- •History of ILD requiring steroid treatment, current ILD, or ≥Grade 2 radiation pneumonitis;
- •Concurrent pulmonary disease resulting in clinically significant respiratory impairment;
Arms & Interventions
Control group
Participants receive capecitabine, gemcitabine, 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: capecitabine
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 capecitabine, gemcitabine, 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: gemcitabine
Control group
Participants receive capecitabine, gemcitabine, 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
Objective Response Rate (ORR)
Time Frame: Up to approximately 24 months
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
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.
Secondary Outcomes
- Duration of Response (DOR)(Up to approximately 24 months)
- T1/2(Up to approximately 24 months)
- Anti-drug antibody (ADA)(Up to approximately 24 months)
- Progression-free survival (PFS)(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Cmax(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)