A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • BL-M07D1
  • Pembrolizumab

Treatment groups

80 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator