OncoMatch/Clinical Trials/NCT06505824
A Study of BL-M14D1 in Patients With Locally Advanced or Metastatic Small Cell Lung Cancer, Neuroendocrine Tumors and Other Solid Tumors
Is NCT06505824 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BL-M14D1 for small cell lung cancer.
Treatment: BL-M14D1 — This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M14D1 in locally advanced or metastatic solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Neuroendocrine Tumor
Disease stage
Metastatic disease required
locally advanced or metastatic solid tumors that are incurable or currently have no standard treatment; Must have at least one measurable lesion according to RECIST v1.1 definition
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy or biological therapy
Exception: within 4 weeks or 5 half-lives before the first dose
Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose
Cannot have received: mitomycin (mitomycin)
Exception: within 6 weeks before the first dose
Mitomycin and nitrosoureas were administered within 6 weeks before the first dose
Cannot have received: nitrosoureas (nitrosoureas)
Exception: within 6 weeks before the first dose
Mitomycin and nitrosoureas were administered within 6 weeks before the first dose
Cannot have received: oral antineoplastic drugs (fluorouracil)
Oral drugs such as fluorouracil
Cannot have received: antibody-drug conjugate
Exception: with a TOPI inhibitor as a toxin
Prior receipt of an ADC drug with a TOPI inhibitor as a toxin
Cannot have received: anthracycline
Exception: cumulative dose > 360 mg/m2 in previous (new) adjuvant therapy
Anthracycline cumulative dose > 360 mg/m2 in previous (new) adjuvant therapy
Lab requirements
Blood counts
Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0; The level of organ function must meet the requirements on the premise that blood transfusion is not allowed within 14 days before the screening period and no cell growth factor drugs are allowed; Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN; The urine protein + 2 or 1000 mg / 24 h or less or less
Kidney function
Liver function
Cardiac function
No severe cardiac dysfunction, left ventricular ejection fraction ≥50%
No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; The level of organ function must meet the requirements...Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN; The urine protein + 2 or 1000 mg / 24 h or less or less
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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