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Recruiting Phase 1

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

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About this study

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.

Condition
Non Small Cell Lung Cancer, Solid Tumor
Tested
BL-M24D1
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 16

  • Minimum age: 18 years
  • Study condition: Non Small Cell Lung Cancer, Solid Tumor
  • 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.

Exclusion 21

  • 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

1 site, 1 recruiting

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.