Trial Title:
Clinical Trial of BT02 in Patients With Advanced Solid Tumors
NCT ID:
NCT06404905
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Antibodies
Antibodies, Monoclonal
Conditions: Keywords:
Advanced Solid Tumors
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Open Label
Intervention:
Intervention type:
Drug
Intervention name:
BT02 monoclonal antibody injection
Description:
It is expected to include 13-30 patients assigned to 5 dose escalation cohorts (0.3
mg/kg, 1.0 mg/kg, 3.0 mg/kg, 8.0 mg/kg, 10.0 mg/kg, every 2 weeks of a 4-week cycle)
sequentially.
Arm group label:
BT02 treatment
Summary:
A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability,
Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients
with Advanced Solid Tumors
Detailed description:
Overall study design:
This is an open-label, FIH, Phase I / II study of BT02 to evaluate the safety,
tolerability, PK, immunogenicity, and preliminary antitumor activity of BT02 in adult
patients with advanced solid tumors.
Safety monitoring committee (SMC) will be appointed for this study. The SMC includes the
PIs, sub-Is, sponsor representatives, and/ or independent experts, to monitor the safety
and scientific integrity of a human research intervention, and to make recommendations to
the sponsor to continue, amend, or stop the study based on safety findings, efficacy, or
for futility. The medical monitor will conduct a monthly systematic medical monitoring of
the data during the study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 at the time of signing the informed consent form, male or female;
2. Patients must have histologically or cytologically confirmed diagnosis of advanced
solid tumor that is refractory to or intolerant of standard therapy or for which no
standard therapy is available, or standard treatment not applicable;
3. Adequate organ and hematologic function:
1. Hematologic (without transfusion or hematopoietic stimulating factor treatment
within 14 days before study treatment)
1. Absolute neutrophil count (ANC) ≥1.5×109/L
2. Lymphocyte count ≥ 0.5×109/L
3. Platelet count (PLT) ≥100×109/L, PLT ≥ 80×109/L for patients with
epatocellular carcinoma (HCC)
4. Hemoglobin (Hb) ≥9.0 g/dLb) Hepatic
1. Total bilirubin (TBIL) ≤1.5×ULN, ≤3×ULN for patients with liver metastases
or skeptically gilbert's disease
2. Alanine aminotransferase (ALT) / Aspartate; transaminase (AST) ≤ 2.5×ULN ；
≤5×ULN for patients with liver metastases;
c) Renal
1) Creatinine clearance rate (Ccr)>50 ml/min; (Calculated by Cockcroft-Gault formula).
d) Coagulation
1) International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (APTT)
≤ 1.5×ULN 4. Patients must have at least measurable or evaluable lesion in phase I
and measurable lesion in phase II according to RECIST 1.1(Tumor lesions that are
situated in a previously irradiated area might not be considered measurable, unless
there is sufficient evidence to show a clear imaging progression after
radiotherapy); 5. ECOG performance status 0~1; 6. Life expectancy ≥ 3 months; 7. For
Eligible patients of childbearing potential (male and female) must agree to use
effective methods of birth control (hormonal or barrier method or abstinence) during
the study and for at least 6 months after the last dose of study drug. Female
patients of childbearing potential must have a negative serum pregnancy test within
7 days before enrollment; 8. Good compliance and be willing to follow-up visit.
Exclusion Criteria:
1. Receive treatment before study as below:
1. Previous systematic anti-cancer therapy, including chemotherapy, radiotherapy,
biological therapy, cytokine therapy, endocrine therapy, molecular targeted
therapy or immunotherapy within 4 weeks prior to the first dose of study
treatment, except for the following circumstances:
1. 6 weeks for nitrosourea or mitomycin C
2. 2 weeks or 5-halflife (whichever is longer) for oral fluoropyrimidines and
small molecule targeting agents
3. 2 weeks for traditional Chinese medicines with anti-tumor indications
4. palliative bone directed radiotherapy
5. erythropoietin
2. Major elective surgery (excluding needle biopsy) was planned during the
screening period.
3. Patients receiving immunosuppressive agents (such as steroids) for any reason
should be tapered off these drugs before initiation of the study treatment
(with the exception of patients with adrenal insufficiency, who may continue
corticosteroids at physiologic replacement dose, equivalent to ≤ 10 mg
prednisone daily). Steroids with no or minimal systemic effect (topical,
inhalation) are allowed.
4. Patients receiving systemic immune stimulants within 4 weeks or 5-halflife
(whichever is longer)
5. Treatment with any other investigational agent within 4 weeks prior to study
treatment initiation
2. Active or prior documented autoimmune disease within past 2 years (refer to Appendix
5), which may relapse (such as systemic lupus erythematosus, rheumatoid arthritis,
vasculitis, Crohn's disease, etc.). Patients with vitiligo, Grave's disease,
Hashimoto's disease, or psoriasis not requiring systemic treatment (within the past
2 years) are not excluded.
3. History of clinically significant cardiovascular disease:
1. Severe heart rhythm or conduction abnormalities, such as ventricular arrhythmia
that requires clinical intervention, Ⅱ-Ⅲ degree atrioventricular block, QTc
interval >480 ms, etc.;
2. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke,
or other cardiovascular and cerebrovascular events of grade 3 or above occurred
within the 6 months prior to the first dose of study drug
3. New York Heart Association (NYHA) class II or greater cardiac disease or left
ventricular ejection fraction (LVEF) <50%
4. Clinically uncontrollable hypertension
4. Significant acute or chronic infections including, among others:
1. Known history of testing positive test for human immunodeficiency virus (HIV)
2. If the patients with active hepatitis B (Positive tests for HBsAg and HBV-DNA,
or hepatitis C virus infection (Positive tests for anti-HCV or HCV-RNA) have
been undergoing suitable treatment to control disease, and developing special
enrollment and visit medical examination plans for them, receiving medication
treatment if needed, these patients could be included.
3. Interstitial lung disease, or obstructive pulmonary disease, or history of
symptomatic bronchospasm, or Inadequate pulmonary function defined as oxygen
saturation <93%, or any other active or history of significant lung
disease may cause severe dyspnea
5. Prior toxicities from anti-cancer therapies have not regressed to grade ≤1 severity
(except for those without safety risks as judged by investigators, such as alopecia,
grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement
therapy, etc.)
6. Any prior Grade≥3 irAE while receiving immunotherapy, including
anti-CTLA-4/anti-PD-L1 treatment, or any unresolved irAE > Grade 1; Known
allergy or reaction to any component of the BT02 formulation;
7. Unstable brain metastasis or meningeal metastasis with clinical symptoms, which is
not suitable based on the investigator's judgment;
8. Previous malignant disease other than the target malignancy to be investigated in
this trial within the last 5 years with the exception of basal or squamous cell
carcinoma of the skin or cervical carcinoma in situ.
9. Vaccination within 4 weeks of the first dose of BT02 and while on study is
prohibited except for administration of inactivated vaccines (e.g. inactivated
influenza vaccines).
10. Patients with mental disorders or poor compliance;
11. Known alcohol or drug abuse;
12. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive human chorionic gonadotropin (hCG) laboratory test within 7 days prior to
the start of study drug;
13. Other severe systemic diseases or conditions that unsuitable for participating in
this study in the opinion of the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Institute and Hospital
Address:
City:
Beijing
Zip:
1000021
Country:
China
Status:
Recruiting
Contact:
Last name:
Ning Li, Doctor
Phone:
800-555-5555
Email:
lining@cicams.ac.cn
Investigator:
Last name:
Li, Doctor
Email:
Principal Investigator
Start date:
January 24, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06404905
