A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects With Advanced Solid Tumors

Inclusion criteria

• Male or female subjects aged ≥ 18 years old.
• Subjects with locally advanced, or metastatic solid tumors confirmed histologically or cytologically as one of the following cancer types for whom no suitable alternative standard-of-care therapy exists:

• Non-small cell lung cancer (NSCLC);
• Ovarian cancer (OC);
• Head and neck carcinoma (H&N);
• Breast cancer (BC);
• Colorectal cancer (CRC).
• Pathologically confirmed combined positive score (CPS) with ≥ 1% expression of PD-L1.
• At least one measurable lesion
• Adequate organ function
• Female subject must either not be of childbearing potential or a negative pregnancy test
• Non-vasectomized male subjects must practice highly effective contraception

Exclusion criteria

• Active bacterial, fungal, viral OR atypical infection requiring systemic medication.
• Received any investigational drug within 4 weeks before screening.
• Confirmed active HIV (without controlled disease on HAART), HBV, or HCV infection.
• Symptomatic, unstable central nervous system malignancy OR metastasis
• Have received organ or tissue transplantation or allogeneic cell therapies.
• Non-adequate cardiac function
• Known hypersensitivity to any anti-PD-L1 therapy or anti-CD3 therapy.