A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer and Other Solid Tumors

Recruiting now · Phase 1

Conditions studied: Non Small Cell Lung Cancer, Solid Tumor

In brief

This study is an open, multicenter, non-randomized phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M24D1 in patients with locally advanced or metastatic non-small cell lung cancer and other solid tumors.

Key facts

Study ID: NCT07232420
Run by: Sichuan Baili Pharmaceutical Co., Ltd.
People needed: 33
Starts: 2025-11-11
Expected to finish: 2027-12-01
Last updated by the study team: 2025-11-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Voluntarily sign the informed consent form and comply with the protocol requirements;
Gender unrestricted;
Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
Expected survival time ≥3 months;
Locally advanced or metastatic non-small cell lung cancer and other solid tumors;
Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 3 years;
Must have at least one measurable lesion meeting the RECIST v1.1 criteria;
ECOG performance status score of 0 or 1;
Toxicities from prior antitumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
Organ function levels must meet the requirements;
Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN;
Urine protein ≤2+ or ≤1000mg/24h;
For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and they must not be breastfeeding; all enrolled patients (regardless of gender) should use adequate barrier contraception throughout the treatment cycle and for 6 months after treatment ends.

You may not qualify if…

Use of chemotherapy, biotherapy, or immunotherapy within 4 weeks or 5 half-lives prior to the first dose;
History of severe heart disease;
QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;
Active autoimmune or inflammatory diseases;
Diagnosis of other malignancies within 5 years prior to the first dose;
Hypertension poorly controlled by two antihypertensive medications;
Poorly controlled blood glucose;
Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
Lung diseases graded ≥3 according to CTCAE v5.0;
Symptoms of active central nervous system metastasis;
History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M24D1;
Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
Cumulative dose of anthracyclines >360 mg/m² in previous (neo)adjuvant anthracycline therapy;
Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
History of interstitial lung disease requiring hormonal treatment, or current ILD;
Active infection requiring systemic treatment within 4 weeks prior to the first investigational drug dose;
Pleural, peritoneal, pelvic, or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first investigational drug dose;
Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to the first investigational drug dose;
Participation in another clinical trial within 4 weeks prior to the first dose;
Pregnant or lactating women;
Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Where it is running

Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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