A Study of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors

• Drug: AP402 (Part 1 Dose esclation)
• Drug: AP402 (Part 2 Dose Expansion)

Inclusion Criteria:

1. Patients with histologically or cytologically proven locally unresectable advanced or metastatic HER2-postive solid tumors which no standard therapy suitable.
2. Adult patients aged ≥ 18 years at the time of signing 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 (ICF).
3. Written informed consent by the patients or the patient’s legally authorized representative prior to Screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening.
4. Patients with Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 to 1 at study enrollment and an estimated life expectancy of at least 3 months.
5. Disease must have at least 1 measurable (long diameter ≥ 1cm) lesion by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Tumor lesions situated in a previously irradiated area are not considered assessable unless there has been demonstrated progression in the lesion. Imagingtests that create detailed images of areas inside the body tests outside the screening period are valid if performed not more than 2 weeks before consent signature and otherwise fulfil protocol criteria.
6. Patients with adequate organ function defined by the following:
   1. Absolute neutrophil count ≥ 1.5 × 109 /L.
   2. Platelet count ≥ 100 × 109 /L.
   3. Hemoglobin ≥ 9 g/dL.
   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or < 5 × ULN if hepatic metastases present.
   5. Serum total bilirubin ≤ 1.5 × ULN (or < 3 × ULN for patients with Gilbert’s syndrome).
   6. Alkaline phosphatase ≤ 2.5 × ULN or < 5 × ULN if bone metastases present.
   7. Prothrombin time ≤ 1.5 × ULN.
   8. International normalized ratio (INR) ≤ 2.0 or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Exception: INR 2 to ≤ 3 is acceptable for patients on a stable dose of anticoagulants.
   9. Estimated creatinine clearance > 45 mL/min according to the Cockcroft Gault formula.
   10. Albumin ≥ 28 g/L NOTE: Patients must not have required bloodthe red bodily fluid that transports oxygen and other nutrients around the body transfusions or growth factor support ≤ 14 days before sample collection at Screening.
7. Females must not be pregnant or lactating, and must use acceptable, highly effective double contraception from Screening until 90 days after study completion, including the Follow-up period. Effective forms of contraception are defined in Section 7.3.2. Females with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Day 1 and be willing to have additional pregnancy tests as required throughout the study. Women not of childbearing potential must be postmenopausal for ≥12 months (postmenopausal status is to be confirmed through testing of FSH levels ≥ 40 IU/L at Screening for amenorrhoeic female patients).
8. Males must be surgically sterile (>30 days since vasectomy with no viable sperm), or if engaged in sexual relations with a WOCBP, either his partner must be surgically sterile (eg, tubal occlusion, hysterectomycomplete or partial removal of the uterus, bilateralaffecting both sides salpingectomyremoval of one (unilateral) or both (bilateral) fallopian tubes, bilateral oophorectomyremoval of one (unilateral) or both (bilateral) ovaries), or an acceptable, highly effective contraceptive method (see Section 7.3.2) must be used from Screening until study completion, including the Follow-up period. Males with same-sex partners (abstinence from penile-vaginal intercourse) or are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Males must not donate sperm from the first dose of IP until at least 90 days after the last dose of IP.