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.
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;
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;
Single group
BL-M07D1
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Pembrolizumab
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Objective Response Rate (ORR)
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
The combined optimal dosage will be investigated.
Combination method
The combination method will be investigated.
Progression-free Survival (PFS)
The PFS is defined as the time from the participant's first dose of BL-M07D1 to the first date of either disease progression or death, whichever occurs first.
Disease Control Rate (DCR)
The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]).
Duration of Response (DOR)
The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
Overall survival (OS)
Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
