This is a multi-regional, multi center, open label, first in human (FIH), dose-escalation, and dose-expansion study of AP203 to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and antitumor activities of AP203 in adult patients with locally advanced or metastatic solid tumors.
Dose escalation Phase and Dose expansion Phase
Written informed consent by the participants or the participant's legally authorized representative prior to screening.
Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at study enrollment and an estimated life expectancy of at least 3 months.
Disease must have at least 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Tumor lesions situated in a previously irradiated area are not considered measurable unless there has been demonstrated progression in the lesion. Imaging tests outside the screening period are valid if performed not more than 2 weeks before consent signature and otherwise fulfil protocol criteria.
Participants who have received concurrent antitumor treatment or investigational products within 28 days or 5 half lives, whichever is shorter before the start of study intervention (e.g., chemotherapy, radiotherapy [with the exception of palliative bone directed radiotherapy], immunotherapy, targeted therapy, hormonal therapy, or cytokine therapy except for erythropoietin).
Participants who had major surgery within 28 days before the start of study intervention (excluding prior diagnostic biopsy).
Participants who had continuance of toxicities due to prior antitumor agents that have not resolved to Grade ≤ 1 per NCI CTCAE version 5.0, except alopecia, < Grade 2 sensory neuropathy.
Participants with a history of immune mediated AE of any grade that resulted in discontinuation of prior immunotherapy.