Trial Title:
A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies
NCT ID:
NCT05803018
Condition:
Gynecological Malignant Tumor
Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Ovarian Cancer
Endometrial Carcinoma
Cervical Cancer
Tubal carcinoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BL-B01D1
Description:
Administration by intravenous infusion
Arm group label:
Study treatment
Summary:
Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and
efficacy of BL-B01D1 for injection in patients with multiple solid tumors, including
recurrent or metastatic gynecological malignancies
Detailed description:
Phase Ib: To explore the safety and initial efficacy of BL-B01D1 in a variety of solid
tumors, including recurrent or metastatic gynecological malignancies, to further identify
RP2D. To evaluate the initial efficacy of BL-B01D1. The pharmacokinetic characteristics
and immunogenicity of BL-B01D1 were further evaluated. Phase II: To explore the efficacy
of BL-B01D1 as a single agent RP2D in patients with multiple solid tumors such as
recurrent or metastatic gynecological malignancies using Phase Ib clinical studies. To
evaluate the safety and tolerance of BL-B01D1. To evaluate the pharmacokinetic
characteristics and immunogenicity of BL-B01D1.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Sign the informed consent voluntarily and follow the program requirements;
2. Age: ≥18 years old and ≤75 years old;
3. Expected survival time ≥3 months;
4. Recurrent or metastatic gynecological malignancies (including but not limited to
ovarian cancer, endometrial cancer, cervical cancer, fallopian tube cancer) and
other solid tumors confirmed by histopathology and/or cytology that have failed or
been intolerant to standard treatment or currently have no standard treatment; The
so-called intolerance refers to grade 3-4 adverse reactions after receiving standard
treatment, and the patient refuses to continue the original treatment.
5. Agree to provide archived tumor tissue samples (10 unstained sections (anti-slip)
surgical specimens (4-5μm thickness) or fresh tissue samples of primary lesion or
metastasis within 3 years. If the subject is unable to provide tumor tissue samples,
he/she can be enrolled in the study after evaluation by the investigator under the
condition that other inclusion criteria are met;
6. There must be at least one measurable lesion consistent with the RECIST v1.1
definition;
7. Physical condition score ECOG 0 or 1;
8. The toxicity of previous antitumor therapy has returned to ≤ grade 1 as defined by
NCI-CTCAE v5.0 (the investigators considered asymptomatic laboratory abnormalities
such as elevated ALP, hyperuricemia, elevated blood glucose, etc., and toxicities
without safety risks as determined by the investigators, such as hair loss, grade 2
peripheral neurotoxicity, or decreased hemoglobin but ≥90g/L);
9. No serious cardiac dysfunction, left ventricular ejection fraction ≥50%;
10. 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. Kidney function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50
mL/min (based on Cockcroft and Gault's formula, see Appendix 5).
11. Coagulation function: International Normalized ratio (INR) ≤1.5, and activated
partial thromboplastin time (APTT) ≤1.5ULN;
12. Pregnancy tests must be performed within 7 days prior to the start of treatment for
premenopausal women who are at risk of having children, serum or urine pregnancy
tests must be negative and must be non-lactating; All enrolled patients should take
adequate barrier contraception throughout the treatment cycle and 6 months after the
end of treatment.
Exclusion Criteria:
1. Antitumor therapy such as chemotherapy, biotherapy, immunotherapy, radical
radiotherapy, major surgery (as defined by the investigators), and targeted therapy
(including small-molecule tyrosine kinase inhibitors) within 4 weeks prior to
initial administration or within 5 half-lives, whichever is shorter; Mitomycin and
nitrosourea were administered within 6 weeks before the first administration; Oral
fluorouracil drugs such as Tizio, capecitabine, or palliative radiotherapy within 2
weeks before first administration; The duration of radiotherapy or surgery for brain
metastases was 4 weeks.
2. History of severe cardiovascular and cerebrovascular diseases, including but not
limited to:
1. Severe cardiac rhythm or conduction abnormalities, such as ventricular
arrhythmias and degree III atrioventricular block that require clinical
intervention;
2. Prolonged QT interval at rest (QTc > 450 msec in men or 470 msec in women);
3. Myocardial infarction, unstable angina, angioplasty or stenting,
coronary/peripheral artery bypass grafting, class III or Ⅳ congestive heart
failure, cerebrovascular accident, or transient ischemic attack within 6 months
prior to initial administration;
3. Active autoimmune diseases and inflammatory diseases, such as systemic lupus
erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis,
inflammatory bowel diseases, Hashimoto's thyroiditis, etc., except type I diabetes
mellitus, hypothyroidism that can be controlled by alternative therapy alone, and
skin diseases that do not require systemic treatment (e.g. Vitiligo, psoriasis);
4. There are other malignancies that have progressed or require treatment within 5
years prior to initial administration, with the following exceptions: basal cell
carcinoma of the skin after radical treatment, squamous cell carcinoma of the skin,
superficial bladder carcinoma, carcinoma in situ after radical resection, such as
carcinoma in situ of the breast, and prostate cancer; Remarks: Subjects with
localized low-risk prostate cancer (defined as stage ≤T2a, Gleason score ≤6, and PSA
< 10ng/mL (as measured) at the time of prostate cancer diagnosis were eligible to
participate in this study after radical treatment and without biochemical recurrence
of prostate-specific antigen (PSA));
5. Patients with interstitial lung disease (ILD) who were defined as ≥3 lung diseases
according to CTCAE v5.0;
6. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis and
pulmonary embolism requiring therapeutic intervention within the first 6 months of
screening; Thrombus formation associated with infusion set is excluded;
7. Patients with central nervous system (CNS) metastasis and/or cancerous meningitis
(meningeal metastasis). But have received brain metastases (radiation or surgery;
Patients with stable BMS with BMS < 10mm in length and diameter who had stopped
radiotherapy and surgery 28 days before the first dose were admitted. Patients with
cancerous meningitis (meningeal metastasis) were excluded even after treatment and
judged to be stable. The definition of stability should meet the following four
requirements:
1. The seizure-free state persists for > 12 weeks with or without antiepileptic
drugs;
2. Glucocorticoid use is not required;
3. Two consecutive MRI scans (at least 4 weeks between scans) showed stable
imaging status;
4. Asymptomatic and stable for more than 1 month after treatment;
8. Symptomatic and poorly controlled chest, abdomen and pelvic effusion and pericardial
effusion;
9. Patients with a history of allergy to recombinant humanized antibody or mouse
chimeric antibody or to any excipients of BL-B01D1;
10. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation
(Allo-HSCT);
11. Positive human immunodeficiency virus antibody (HIVAb), active tuberculosis, active
hepatitis B virus infection (HBV-DNA copy number > 103) IU/ml) or active hepatitis C
virus infection (HCV antibody positive and HCV-RNA > lower limit of detection) or
novel coronavirus infection (novel coronavirus nucleic acid test positive);
12. Active infections requiring systemic treatment, such as severe pneumonia,
bacteremia, sepsis, etc.;
13. Other conditions deemed unsuitable for participation in this clinical trial by the
investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University ShangHai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Weijing Zhang
Phone:
021-64175590-88503
Email:
JJYIN555@163.com
Investigator:
Last name:
Xiaohua Wu
Email:
Principal Investigator
Investigator:
Last name:
Jian Zhang
Email:
Principal Investigator
Start date:
June 25, 2023
Completion date:
June 2025
Lead sponsor:
Agency:
Sichuan Baili Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Baili-Bio (Chengdu) 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/NCT05803018
