A Phase Ia/Ib Clinical Study of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors

Inclusion Criteria:

1. Willing to participate in the clinical trial, understand and sign the informedconsent, and comply with the study visits and procedures.

2. Men or women ≥18 years old.

3. Men or women with MTAP-Deleted Advanced Solid Tumors.

4. Subjects with solid tumors must have at least one evaluable lesion which shouldbe measurable by RECIST v1.1.

5. Eastern Cooperative Oncology Group (ECOG) performance status (Table 12) 0 to 1.

6. Survival expectations ≥ 12 weeks.

7. Subjects with adequate organ function and the laboratory test critera.

8. Serum pregnancy test (for female of childbearing potential) negative within 7days prior to first dosing of study treatment. Male and female subjects ofchildbearing potential must agree to use effective methods of contraceptionfrom the time of ICF signed, throughout the study and for 6 months after thelast dose of the investigational product. A patient is of childbearingpotential if, in the opinion of the Investigator, he/she is biologicallycapable of having children and is sexually active.

Exclusion Criteria:

1. Subject has not recovered from a prior surgical procedure or has undergone anymajor surgery within 4 weeks prior to the first dose.

2. Known (including suspected) allergic to GH56 or its components.

3. Has received any anti-tumor agents within 28 days without delayed toxicity forthe treatment of advanced tumors prior to the first administration of GH56Capsule or has received radiation therapy, biologic therapy, endocrine therapy,targeted therapy, immunotherapy, or other anti-tumor drug treatments within 28days prior to the first administration of GH56 Capsule, or other anti-tumordrugs or treatments within the following interval before the firstadministration of GH56 Capsule.

4. Has symptomatic or active progressive central nervous system (CNS) metastasessuch as molluscum contagiosum metastases.

5. Subjects who have difficulty in swallowing and have a history ofgastrointestinal surgery or other relevant medical disorders that may interferewith the absorption of GH56.

6. Subjects had a malignant tumor other than the current tumor within 5 yearsprior to the first administration of GH56 Capsule, except for localized cancersthat have been apparently cured or without disease progression or recurrencefor at least 5 consecutive years.

7. Uncontrolled or significant cardiovascular disease

8. Subjects with documented positive virology status of hepatitis, as confirmed byScreening hepatitis B virus (HBV) and hepatitis C virus (HCV) tests, HumanImmunodeficiency Virus (HIV).

9. Conditions that the investigator considers inappropriate for participation inthis clinical trial.