Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors

Inclusion Criteria:

1. Subjects are able to understand and willing to provide signed informed consent.

2. Male and female subjects of ≥18 years of age, inclusive, at the time of signing theinformed consent.

3. With histologically/cytologically confirmed diagnosis of advanced solid tumors asdescribed below:

4. Cohort 1: HER2 overexpression positive (IHC 3+ or IHC 2+ and evidence of HER2amplification by FISH), unresectable locally advanced, recurrent, or metastaticgastric cancer, patients must be previously untreated with systemic treatment;Subject that received neoadjuvant chemotherapy with recurrence >6 months fromcompletion of therapy are permitted.

5. Cohort 2: Unresectable locally advanced, recurrent, or metastatic gastriccancer, progression on or after first-line standard treatment; Priorneoadjuvant or adjuvant therapy can be counted as a line of therapy if thesubject progressed on or within 6 months of completing neoadjuvant or adjuvanttherapy.

6. Cohort 3: Advanced or metastatic colorectal cancer, RAS (KRAS, NRAS) gene iswild-type, and no BRAF V600E mutation has been identified, progression on orafter first-line standard treatment; Prior neoadjuvant or adjuvant therapy canbe counted as a line of therapy if the subject progressed on or within 6 monthsof completing neoadjuvant or adjuvant therapy.

7. Cohort 4: Recurrent unresectable (local or regional) or stage IV (M1)triple-negative breast cancer TNBC, whose tumors express PD-L1 with a CPS ≥ 10,patients must be previously untreated with systemic treatment; Subject thatreceived neoadjuvant chemotherapy with recurrence >6 months from completion oftherapy are permitted.

8. Have adequate organ function, as indicated by the following laboratory parametersbelow (had not received a blood transfusion, apheresis infusion, erythropoietin,granulocyte colony-stimulating factor, and other relevant medical support within 14days before the administration of the first dose of study intervention).

Exclusion Criteria:

1. With a known history of hypersensitivity to any components of the studyintervention.

2. Subjects who have other malignancies requiring treatment within 2 years before thefirst dose of study intervention will be excluded, except for radically treatedlocally curable basal or squamous cell skin cancer and other malignancies that havebeen treated with no relapse within 2 years.

3. Subjects who have undergone any investigational or approved systemic cancer therapy (including chemotherapy, immunotherapy, hormonal therapy, and herbal/alternativetherapies with anti-cancer indications or targeted therapy) within 14 days or 5half-lives, whichever is longer, before the first dose of the study intervention.

4. Subjects who have received any treatment targeting the CD47 or SIRPα pathway.

5. An uncontrolled acute infection.

6. Known to have a history of alcoholism or drug abuse.

7. Any other medical (e.g., Child-Pugh class B or C, pulmonary, metabolic, congenital,endocrinal or CNS disease, etc.), psychiatric, or social condition deemed by theInvestigator to be likely to interfere with a subject's rights, safety, welfare orability to sign informed consent, cooperate and participate in the study, orinterfere with the interpretation of the results.