HX044-I-01: This study will evaluate a new drug (called HX044) to determine the safety and appropriate dose level in people with advanced solid cancersA Phase I/IIa, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HX044 in Patients With Advanced Solid Tumor Malignancies

Exclusion

1. Prior malignancy active within the previous 5 years except for the tumor for which a subject is enrolled in the study and locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
2. Receipt of any anticancer (chemotherapy, radiation therapy, investigational drugs including small molecular inhibitors, endocrine therapy, immunotherapy) therapy within 4 weeks prior to the first dose of study treatment or 5 half-lives of the therapy, whichever is shorter.

3. Severe cardiovascular disease including symptomatic congestive heart failure (New York Heart Association class III or IV), unstable angina, uncontrolled hypertension, cardiac arrhythmia, a history of myocardial infarction within 6 months or a history of arterial thromboembolic event and pulmonary embolism within 3 months of the first dose of investigational agent, as follows:

   • QT/QTc interval prolongation (using Fredericia's QT correction formula) at baseline, Female > 470 ms, Male > 450 ms;
   • Medications to prolong the QT/QTc interval are currently being taken;
   • Family history of long QT syndrome.

4. Patients with a history of or presently experiencing an active autoimmune disease within 2 years of initiating study drug, or those who are at high risk of relapse ; however, subjects with the following are allowed to enroll:

   • Type I diabetes that is stable after a fixed dose of insulin or other hypoglycemic;
   • Only requiring hormone replacement therapy for autoimmune hypothyroidism;
   • Skin disease that does not require systemic treatment such as eczema rash that accounts for <10% of the body surface, psoriasis without ophthalmic symptoms.
5. Subjects who received any major surgery within 4 weeks before the first dose of study treatment (except for diagnostic surgery), and/or subjects who may require major surgery during the study.
6. Lung diseases such as, interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, interstitial pneumonia. Patients with well controlled chronic obstructive pulmonary disease (COPD) are allowed.
7. Subjects with primary central nervous system (CNS) malignancies, symptomatic CNS metastases, symptomatic parenchymal brain leptomeningeal disease or spinal cord compression, except for the following: who has received prior treatment (surgery/radiotherapy) before signing informed consent form (ICF) and is clinically stable for at least 3 months is allowed (prior treatment with corticosteroids are permitted but must stop 14 days before commencing study treatment）
8. Use of any live vaccines within 4 weeks before the first dose of study treatment.
9. A history of psychotropic substance abuse who is unable to quit.
10. Any patient with an uncontrolled illness such as cardiovascular and cerebrovascular diseases, diabetes, high blood pressure, et, and other severe, acute or chronic medical or psychiatric diseases or laboratory abnormalities that, in the Investigator's opinion, may increase the study-related risks or interfere with the interpretation of the findings.