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OncoMatch/Clinical Trials/NCT06114511

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

Is NCT06114511 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies BL-M07D1 for non-small cell lung cancer.

Phase 1/2RecruitingSichuan Baili Pharmaceutical Co., Ltd.NCT06114511Data as of May 2026

Treatment: BL-M07D1This 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) sensitive mutation

Confirmed known HER2-sensitive mutations

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: platinum-based chemotherapy — advanced/metastatic

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

Must have received: immunotherapy — advanced/metastatic

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

Cannot have received: antibody-drug conjugate containing a camptothecin derivative (topoisomerase I inhibitor)

Prior treatment with an ADC drug containing a camptothecin derivative (topoisomerase I inhibitor) as a toxin

Lab requirements

Blood counts

Kidney function

Liver function

Cardiac function

no severe cardiac dysfunction, left ventricular ejection fraction ≥50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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