A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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%.

Trial design

Treatments tested in this trial

  • BL-M07D1

Treatment groups

98 Participants
are divided into 1 treatment group