Trial Title:
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors
NCT ID:
NCT05949619
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BL-M02D1
Description:
Administration by intravenous infusion
Arm group label:
Study treatment
Summary:
Phase Ib: To explore the safety and preliminary efficacy of BL-M02D1 to further define
RP2D in a variety of solid tumors such as locally advanced or metastatic non-small cell
lung cancer. Phase II: To explore the efficacy of BL-M02D1 using single-agent RP2D
obtained from phase I clinical studies.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily sign the informed consent and follow the requirements of the protocol;
2. No gender limit;
3. Age: ≥18 years old;
4. expected survival time ≥3 months;
5. Histologically and/or cytologically confirmed locally advanced or metastatic
non-small cell lung cancer and other solid tumors that have failed standard
treatment;
6. Consent to provide archival tumor tissue specimens (10 unstained sections
(anti-slip) surgical specimens (thickness 4-5μm)) or fresh tissue samples from
primary or metastatic lesions within 3 years. If participants cannot provide tumor
tissue samples, they can be enrolled if they meet other inclusion and exclusion
criteria, after the evaluation of the investigator;
7. Must have at least one measurable lesion according to RECIST v1.1 definition;
8. ECOG 0 or 1;
9. Toxicity from previous antineochemical therapy has returned to grade 1 or less as
defined by NCI-CTCAE v5.0 (asymptomatic laboratory abnormalities such as elevated
ALP, hyperuricemia, elevated serum amylase/lipase, and elevated blood glucose were
considered by the investigator, and toxicity with no safety risk was judged by the
investigator; Excluding alopecia, grade 2 peripheral neurotoxicity, hypothyroidism
stabilized by hormone replacement therapy, or decreased hemoglobin (≥90g/L).
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. The level of organ function must meet the following requirements and meet the
following standards:
1. Bone marrow function: absolute neutrophil count (ANC) ≥1.5×109/L, platelet
count ≥100×109/L, hemoglobin ≥90 g/L;
2. Liver function: total bilirubin (TBIL≤1.5 ULN), AST and ALT ≤2.5 ULN in
patients without liver metastasis, AST and ALT ≤5.0 ULN in patients with liver
metastasis;
3. Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50
mL/min (according to Cockcroft and Gault formula).
12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated
partial thromboplastin time (APTT) ≤1.5ULN;
13. Urine protein ≤2+ or ≤1000mg/24h;
14. Female subjects of childbearing potential or male subjects with a fertile partner
must use highly effective contraception from 7 days before the first dose until 6
months after the dose. Female subjects of childbearing potential had to have a
negative serum pregnancy test within 7 days before the first dose.
Exclusion Criteria:
1. Antineoplastic therapy, including chemotherapy, biologic therapy, immunotherapy,
definitive radiotherapy, major surgery (investigator-defined), or targeted therapy
(including small-molecule tyrosine kinase inhibitors), has been administered within
4 weeks or 5 half-lives (whichever is shorter) before the first dose; Mitomycin and
nitrosoureas were administered within 6 weeks before the first dose; Oral
fluorouracil drugs such as S-1, capecitabine, or palliative radiotherapy within 2
weeks before the first dose; The TCM with anti-tumor indications was within 2 weeks
before the first administration.
2. Prior treatment with Trop2-targeted ADC drugs or with camptothecin derivatives
(topoisomerase I inhibitors) as toxins;
3. A history of severe cardiovascular and cerebrovascular diseases, including but not
limited to:
1. severe cardiac rhythm or conduction abnormalities, such as ventricular
arrhythmia requiring clinical intervention, third degree atrioventricular
block, complete left bundle branch block, frequent and uncontrollable
arrhythmias, such as atrial fibrillation, atrial flutter, ventricular
fibrillation, and ventricular flutter (except transient);
2. prolonged QT interval at rest (QTc > 450 msec in men or QTc > 470 msec in
women);
3. acute coronary syndrome, congestive heart failure, aortic dissection, stroke,
or other grade 3 or higher cardiovascular and cerebrovascular events occurred
within 6 months before the first dose;
4. patients with New York Heart Association (NYHA) functional class ≥II heart
failure;
4. Patients at risk for active autoimmune disease, or with a history of autoimmune
disease, Including but not limited to Crohn's disease, ulcerative colitis, systemic
lupus erythematosus, sarcoidosis, Wegener syndrome, autoimmune hepatitis, systemic
sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy
(Guillain-Barre syndrome), etc. Exceptions were type I diabetes, hypothyroidism that
was stable with hormone-replacement therapy (including that due to autoimmune
thyroid disease), psoriasis or vitiligo that did not require systemic therapy, and
hypothyroidism that was stable with hormone-replacement therapy.
5. Patients with other malignant tumors within 5 years before the first administration,
except those who have been cured skin squamous cell carcinoma, basal cell carcinoma,
superficial bladder cancer, prostate/cervix/breast cancer in situ and so on are
considered to be eligible for enrollment;
6. Unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring
medical intervention within 6 months before screening; Infusion-related thrombosis
was excluded.
7. Patients with massive or symptomatic effusions, or poorly controlled effusions
(poorly controlled was defined as requiring 2 or more paracentesis within a month).
8. Hypertension poorly controlled by two antihypertensive drugs (systolic blood
pressure > 150 mmHg or diastolic blood pressure > 100 mmHg);
9. Current interstitial lung disease, drug-induced interstitial pneumonia, radiation
pneumonitis requiring steroid therapy, or a history of these diseases;
10. Patients with central nervous system (CNS) metastases and/or carcinomatous
meningitis (meningeal metastases). Patients who had received treatment for brain
metastases (radiotherapy or surgery; Patients with stable brain metastases who had
stopped radiotherapy or surgery 28 days before the first dose were eligible.
Patients with cancerous meningitis (meningeal metastasis) were excluded even if they
were treated and judged to be stable. Stable disease was defined as being
asymptomatic, in stable condition, and not requiring steroid therapy for more than 4
weeks before starting study treatment.
11. Patients with a history of allergy to recombinant humanized antibody or human-mouse
chimeric antibody or any of the excipients of BL-M02D1;
12. Previous history of allogeneic stem cell, bone marrow, or organ transplantation;
13. Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active
hepatitis B virus infection (HBsAg positive or HBcAb positive and HBV-DNA copy
number > central detection lower limit) or hepatitis C virus infection (HCV antibody
positive and HCV-RNA > central detection lower limit);
14. Severe systemic infection occurred within 4 weeks before screening, including but
not limited to severe pneumonia caused by fungi, bacteria, viruses, bacteremia, or
serious infectious complications;
15. A history of autologous or allogeneic stem cell transplantation;
16. Pregnant or lactating women;
17. Other conditions for participation in the trial were not considered appropriate by
the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Caicun Zhou, PHD
Phone:
13301825532
Email:
caicunzhoudr@163.com
Investigator:
Last name:
Caicun Zhou
Email:
Principal Investigator
Start date:
September 4, 2023
Completion date:
August 2025
Lead sponsor:
Agency:
Sichuan Baili Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Baili Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05949619
