The investigational drug, SOA101, is a nanobody-based trispecific antibody T cell engager targeting PD-L1/HLA-G/CD3. This is a Phase I/IIa study including dose-escalation, dose optimization and dose expansion parts to exam safety, tolerability, pharmacokinetics, immunogenecity and efficacy of SOA101 on advanced or metastatic solid tumor treatment.
Male or female subjects aged ≥ 18 years old.
Non-small cell lung cancer (NSCLC);
Ovarian cancer (OC);
Head and neck carcinoma (H&N);
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