Brief Summary
This is the first in human study of BL0020, and the primary objective is to evaluate the safety and tolerability, and determine the maximum tolerated dosethe amount of medication taken (MTD) and recommended phase II dose (RP2D) of BL0020 as a single agent in patients with advancedat a late stage, far along solid tumors.
This study consists of two parts: Part A (dose escalation stage) and Part B (dose expansion stage).
The study includes screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening, treatment and follow-up periods.
In part A, “3+ 3” will be used for dose escalation.
In part B, the dose level and/or enrolled patient population for dose-expansion may be adjusted based on available data on the safety, PK and preliminary efficacy gained from the patients.
Intervention / Treatment
- Drug: BL0020
Inclusion Criteria:
- Volunteer to participate in the study, be able to understand the requirements of a clinical study, and sign informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. form.
- Aged ≥ 18 years, male and female.
- Patients with histologically or cytologically confirmed, unresectable or metastatic advanced solid tumors that have failed despite standard therapy or have no standard therapy exists. TNBC, SCLC, and pancreatic cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs are preferred for the dose expansion phase.
- Patients with at least one measurable lesion per RECIST (v1.1) (applicable to the Part B: dose-expansion stage only).Note: Measurable lesions cannot be selected from the following sites in principle: having received prior radiotherapy or having received other local therapy. If a target lesion at a site that has received prior radiotherapy or other local therapy is the only optional lesion, the progression of the lesion shall be confirmed by the investigator.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status score 0 or 1 at screening.
- Life expectancy period ≥ 12 weeks.
- A male patient must agree to use adequate contraception from screening through at least 3 months after the last dose of investigational product BL0020. Male subjects must also agree not to donate sperm from screening through at least 3 months after the dose of investigational product BL0020. Refer to Section 5.5 for more information on highly effective methods of contraception.
- Women of childbearing potential must have a negative pregnancy test prior to the dosing administration, and agree to use adequate contraception from screening through at least 6 months after the last dose of investigational product BL0020. A female participant of non-childbearing potential will have had at least 12 continuous months of natural (spontaneous) amenorrhoeaabscense of menstrual periods, follicle stimulating hormonea chemical substance produced by glands in the endocrine system that regulates various functions in the body (FSH) level > 40 mIU/mL at screening, and an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms); or have had surgical bilateralaffecting both sides oophorectomy, hysterectomycomplete or partial removal of the uterus or bilateral tubal ligation beyond 6 weeks prior to screening. Refer to Section 5.5 for more information on highly effective methods of contraception.