A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors
Overview
- Phase
- Phase 2
- Intervention
- BL-B01D1
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Enrollment
- 570
- Locations
- 1
- Primary Endpoint
- Recommended Phase II Dose (RP2D)
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 Monoclonal Antibody in patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma and other solid tumors.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sign the informed consent form voluntarily and follow the protocol requirements;
- •Any gender;
- •Age: ≥18 years old;
- •Expected survival time for 3 months or more;
- •Patients with locally advanced or metastatic non-small cell lung cancer or nasopharyngeal carcinoma confirmed by histopathology and/or cytology;
- •Subjects were able to provide 6-10 slides of archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 2 years;
- •At least one measurable lesion meeting the RECIST v1.1 definition was required;
- •ECOG 0 or 1;
- •The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
- •No serious cardiac dysfunction, left ventricular ejection fraction 50% or higher;
Exclusion Criteria
- •Stage 1 EGFR-sensitive mutant non-small cell lung cancer patients with systemic chemotherapy; Stage 2 patients who had received previous systemic therapy;
- •In the second stage queue one signed informed consent before gene sequencing report suggests patients such as mutation of ALK fusion;
- •Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Fluorouracil class oral drugs, etc.;
- •Serious heart disease;
- •Long QT, complete left bundle branch block, III degree atrioventricular block; Serious arrhythmia;
- •Active autoimmune and inflammatory diseases;
- •Before the first delivery within 5 years diagnosed as other malignant tumor;
- •Two antihypertensive drugs poorly controlled hypertension;
- •Patients with poor glycemic control;
- •With a history of ILD, current ILD or suspected suffering from such diseases during screening;
Arms & Interventions
BL-B01D1+PD-1 Monoclonal Antibody
Participants receive BL-B01D1+PD-1 Monoclonal Antibody 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
BL-B01D1+PD-1 Monoclonal Antibody
Participants receive BL-B01D1+PD-1 Monoclonal Antibody 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: PD-1 Monoclonal Antibody
Outcomes
Primary Outcomes
Recommended Phase II Dose (RP2D)
Time Frame: Up to approximately 24 months
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1.
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).
Secondary Outcomes
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Progression-free survival (PFS)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)