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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Participants 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.
China Medical University Hospital
Taichung, Taiwan
RECRUITINGMaximum Tolerated Dose (MTD) of SOA101 for Phase I
Time frame: from start until 3 months after the last dosing
Objective Response Rate (ORR) of SOA101 for Phase IIa
Time frame: from start until 3 months after the last dosing
Area Under the Curve of SOA101 (AUC)
Pharmacokinetics (PK) parameters
Time frame: Up to end of study visit (90 days after the last dose)
Maximum observed plasma concentration of SOA101 (Cmax)
Pharmacokinetics (PK) parameters
Time frame: Up to end of study visit (90 days after the last dose)
Half-life of SOA101 (T1/2)
Pharmacokinetics (PK) parameters
Time frame: Up to end of study visit (90 days after the last dose)
Overall Response Rate (ORR)
Evaluation of anti-tumor activity of SOA101
Time frame: Up to end of study visit (90 days after the last dose)
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