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
Single group
SOA101
DrugParticipants will receive SOA101. The RP2D will be determined based on the results of the Phase I study. During the dose expansion phase, participants will receive SOA101 at the RP2D regimen.
Maximum Tolerated Dose (MTD) of SOA101 for Phase I
Objective Response Rate (ORR) of SOA101 for Phase IIa
Area Under the Curve of SOA101 (AUC)
Pharmacokinetics (PK) parameters
Maximum observed plasma concentration of SOA101 (Cmax)
Pharmacokinetics (PK) parameters
Half-life of SOA101 (T1/2)
Pharmacokinetics (PK) parameters
Overall Response Rate (ORR)
Evaluation of anti-tumor activity of SOA101
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