A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- BL-M07D1
- Conditions
- Not specified
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR)
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
This trial is a multicenter, open-label, Phase II clinical study to explore the efficacy and safety of BL-M07D1 in combination with pembrolizumab in patients with locally advanced or metastatic HER2-overexpressing non-squamous non-small cell lung cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntarily sign the informed consent form and comply with the protocol requirements;
- •No gender restrictions;
- •Age at the time of signing the informed consent form ≥18 years and ≤75 years;
- •Expected survival time ≥3 months;
- •Patients with locally advanced or metastatic non-squamous non-small cell lung cancer;
- •Confirmed known HER2 overexpression;
- •Agree to provide archived tumor tissue specimens from primary or metastatic lesions within the past 2 years;
- •Must have at least one measurable lesion meeting the RECIST v1.1 criteria;
- •ECOG performance status score of 0 or 1;
- •Toxicities from prior anti-tumor treatments have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
Exclusion Criteria
- •Underwent surgical treatment, radical radiotherapy, immunotherapy, etc., within 4 weeks before the first dose or within 5 half-lives;
- •Pathology indicates non-small cell carcinoma containing small cell carcinoma components and sarcomatoid carcinoma;
- •Previously received HER2-targeted therapy or ADC drug treatment with camptothecin derivatives as toxins;
- •History of severe cardiovascular or cerebrovascular diseases within the past 6 months before screening;
- •Concurrent pulmonary disease leading to severe impairment of lung function;
- •QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
- •Diagnosed with other primary malignancies within 5 years before the first dose;
- •Poorly controlled hypertension;
- •History of non-infectious ILD requiring steroid treatment, or currently suffering from ILD/interstitial pneumonia, etc.;
- •Patients with central nervous system metastases, carcinomatous meningitis, and/or spinal cord compression;
Arms & Interventions
BL-M07D1+pembrolizumab
Participants received BL-M07D1+pembrolizumab in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.
Intervention: BL-M07D1
BL-M07D1+pembrolizumab
Participants received BL-M07D1+pembrolizumab in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.
Intervention: Pembrolizumab
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.
Combined optimal dosage
Time Frame: Up to approximately 24 months
The combined optimal dosage will be investigated.
Combination method
Time Frame: Up to approximately 24 months
The combination method will be investigated.
Secondary Outcomes
- Progression-free Survival (PFS)(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)
- Overall survival (OS)(Up to approximately 24 months)
- Cmax(Up to approximately 24 months)
- Tmax(Up to approximately 24 months)
- Ctrough(Up to approximately 24 months)
- Anti-drug antibody (ADA)(Up to approximately 24 months)
- Drug-drug interactions (DDI)(Up to approximately 24 months)
- Treatment-Emergent Adverse Event (TEAE)(Up to approximately 24 months)