A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- BL-B01D1
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Enrollment
- 198
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
A Phase II clinical study to evaluate the efficacy and safety of BL-B01D1 for injection and BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with locally advanced or metastatic non-small cell lung cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sign the informed consent form voluntarily and follow the protocol requirements;
- •Gender is not limited;
- •Age ≥18 years old;
- •Expected survival time ≥3 months;
- •Patients with locally advanced or metastatic non-small cell lung cancer confirmed by histopathology and/or cytology;
- •Consent to provide an archived tumor tissue sample or fresh tissue sample from the primary or metastatic site within 6 months for biomarker testing;
- •At least one measurable lesion meeting the RECIST v1.1 definition was required;
- •The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
- •No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- •The level of organ function must meet the requirements on the premise that no blood transfusion and no use of any cell growth factor drugs are allowed within 14 days before the screening period;
Exclusion Criteria
- •Patients with previous systemic therapy;
- •Cohort\_B and Cohort\_C were previously treated with EGFR-TKI;
- •Who had participated in any other clinical trial within 4 weeks before the study dose;
- •Received chemotherapy, radiotherapy, biological therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of study drugs;
- •Had undergone major surgery within 4 weeks before the first dose;
- •History of severe heart disease and cerebrovascular disease;
- •Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
- •QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- •Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases;
- •Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
Arms & Interventions
Study treatment
Participants receive BL-B01D1 and BL-B01D1 in combination with Osimertinib Mesylate Tablets 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: BL-B01D1
Study treatment
Participants receive BL-B01D1 and BL-B01D1 in combination with Osimertinib Mesylate Tablets 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: Osimertinib Mesylate Tablets
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: Up to approximately 24 months
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
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.
Secondary Outcomes
- Duration of response (DOR)(Up to approximately 24 months)
- Treatment-Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Disease control rate (DCR)(Up to approximately 24 months)
- Progression-free survival (PFS)(Up to approximately 24 months)