A Study Of IMM47 In Subjects With Advanced Solid Tumors

• Drug: IMM47

Inclusion Criteria

1. Age ≥ 18 years at the time of signing the ICF.
2. With an expected life expectancy of ≥ 12 weeks.
3. With an ECOG performance status score of 0-1.
4. For phase Ia, subjects diagnosed histologically or cytologically with advanced solidtumors (preferred but not limited to ovarian, esophageal, breast, lung, colorectalrelating to the colon or rectum in the large bowel/intestine, hepatocellular, pancreatic, urothelial, prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation, and head and neck cancers) that have failed previous standard treatments or no standard treatment is available.
5. The intervals for discontinuing the last anti-tumor therapy prior to the first dosethe amount of medication taken of the investigational product are required as follows Subjects who previously received chemotherapeutic agents must have discontinued the drug for more than 3 weeks.Subjects who previously received small-molecule targeted therapymedication that targets specific molecular features of cancer cells must have discontinued treatment for more than 2 weeks or 5 half-lives of the drug (whichever is longer).

   Subjects who previously received monoclonal antibodies (eg. CD20 antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses, PD-1/PD-L1 antibody) must have discontinued the treatment for more than 4 weeks.

   Subjects who previously underwent palliative radiation therapya treatment that uses controlled doses of radiation to damage or kill cancer cells must have discontinued the treatment for more than 2 weeks.

6. With suitable organ and hematopoietic functions:Neutrophil count ≥1.5 × 109/L. (no growth factor therapy within 4 weeks prior to Screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening).

   Platelet count ≥100 × 109/L ; for subjects with HCC, platelet count ≥75 ×109 /L Hemoglobin ≥ 90 g/L (subjects may be transfused >2 weeks before screening, but should not be transfusion-dependent).

   Total Bilirubin (TBIL) ≤ 1.5 × ULN (or ≤ 3.0 × ULN if subject has a documented history of Gilbert’s syndrome or liver metastases).

   Both aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN (or both AST and ALT ≤ 5.0 × ULN if subject has a documented history of liver metastases).

   International normalized ratio (INR) ≤1.5 × ULN, or activated partial thromboplastin time (APTT) ≤ 1.5× ULN.

   Left ventricular ejection fraction (LVEF) ≥ 50%. Serum creatinine ≤1.5 × ULN or creatinine clearance (CrCl) ≥ 40 mL/min (Cockcroft and Gault Equation) if serum creatinine >1.5 ULN. Lower calculated creatinine clearance values may be allowed at the Investigator’s discretion and in consultation with the Medical Monitorto check on, keep track of and Sponsor

7. Adverse events associated with previous anti-tumor therapies should have recovered to ≤ Gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells 1 (CTCAE version 5.0) (except for toxicities not considered a safety riskthe possibility that something bad will happen such as alopeciathe partial or complete absence of hair from areas of the body where it normally grows; baldness, skin pigmentation, and other non-clinically significant abnormalities).
8. Female subjects (based on sex assigned at birth) of childbearing potential must be tested negative for serum pregnancy test during the screening period before receiving the first administration of IMM47; any female subject of childbearing potential must agree to take effective contraceptive measures during the entire study and within 6 months after last dose of the investigational product. A subject is considered to have childbearing potential if he/she is biologically capable of having children and has a heterosexual sex life. Female subjects meeting at least one of the following criteria are deemed to be without childbearing potential:Has undergone hysterectomycomplete or partial removal of the uterus or bilateralaffecting both sides oophorectomy Medically confirmed with ovarian failure Medically confirmed as postmenopausal (menstruation has stopped for 12 consecutive months not for pathological or physiological reasons)

   Acceptable forms of contraception for female subjects are:

   Should not have sexual intercourse or genital contact with a male partner, or use a method of birth control for the duration of the study participation and for 6 months last dose of the investigational product.

   Must agree to use one form of contraception, including sterilization, combined estrogen and progestogen containing hormonal contraception pills or an intravaginal, transdermal, or intrauterine device.

   Intrauterine hormone-releasing system. Bilateral tubal occlusion (surgical procedure that involves blocking by cutting, burning or removing sections, or placing clips of the fallopian tubes to prevent the ovum [egg] from being fertilized).

   A vasectomized partner (surgical procedure that involves cutting and sealing the tubes used to transport semen from the testicles to the penis, thereby rendering infertility).

   Male subjects with female partners of childbearing potential are eligible to participate if they agree to ONE of the following for the duration of the study and until 90 days after the last dose of the study treatment:

   Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.

   Agree to use a male condom and have their partner use a contraceptive method with a failure rate of <1% per year as described below when having penile-vaginal intercourse with a WOCBP who is not currently pregnant.

   In addition, male subjects must refrain from donating sperm for the duration of the study and for 90 days after the last dose of study treatment.

   Male subjects with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration for the duration of the study and until 90 days after the last dose of the study treatment.

9. Subjects who voluntarily sign the 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, understand the study, and are willing to comply with the protocol, and are able to complete all trial procedures.
10. At least one measurable or evaluable tumor lesion. For solid tumor: Measurable lesion according to RECIST version 1.1 is defined as tumor lesions ≥10 mm in longest diameter or pathologic nodea small lump or mass of tissue in your body ≥ 15 mm in short axis.
11. For both phase Ia and Ib, subjects must agree to provide archived tumor tissuea group of cells that work together to perform a function samples for CD24 IHC expression assessment by the central laboratory. In the setting where archival material is unavailable or unsuitable for use (e.g., recently diagnosed subjects or diagnosed with fine needle aspiration), the subject must consent and undergo fresh tumor biopsyremoval of a section of tissue to analyse for cancer cells (biopsy at acceptable risk as judged by the Investigator). The requirement for fresh biopsy collected from a given subject could be waived after the discussion with the Sponsor, if the tumor tissues are not safely accessible as determined by the Investigator, or the tumor biopsies have to be obtained from sites that require significant risk procedures.