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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

BL-M07D1

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)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06114511 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior antibody-drug conjugate containing a camptothecin derivative (topoisomerase I inhibitor) disqualifies patients from enrollment.

Does this trial require ERBB2?

Yes, ERBB2 sensitive mutation is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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