A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 for Injection in Patients With HER2 Mutated, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
This phase Ib/II study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of injectable BL-M07D1 in patients with HER2-mutated, locally advanced or metastatic non-small cell lung cancer.
• Voluntarily sign the informed consent and follow the requirements of the protocol.
• No gender limit.
• Age: ≥18 years old and ≤75 years old.
• expected survival time ≥3 months.
• Histologically or cytologically confirmed, unresectable locally advanced or metastatic non-small cell lung cancer.
• Confirmed known HER2-sensitive mutations, investigator-confirmed previous testing results, and trial site laboratory testing results were acceptable.
• Patients in the advanced stage who had received platinum-based chemotherapy and immunotherapy concurrent or sequential therapy were unable to tolerate standard treatment or had disease progression during or after treatment.
• Consent to provide archived tumor tissue or fresh tissue samples from primary or metastatic sites within 2 years for biomarker testing; Participants who were unable to provide tumor tissue samples could be enrolled if they met other inclusion and exclusion criteria after evaluation by investigators.
• Must have at least one measurable lesion according to RECIST v1.1 definition.
⁃ ECOG score 0 or 1.
⁃ Toxicity of previous antineoplastic therapy has returned to grade 1 or less as defined by NCI-CTCAE v5.0 .
⁃ No severe cardiac dysfunction, left ventricular ejection fraction ≥50%.
⁃ Organ function levels must meet the requirements.
⁃ Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN.
⁃ Urine protein ≤2+ or ≤1000mg/24h.
⁃ For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, serum/urine pregnancy must be negative, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.