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.
Parallel
AP203
DrugEight dose levels ranging from 0.00064 to 20 mg/kg will be evaluated to determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD) or the recommended phase 2 dose(s) (RP2D\[s\]). Participants will be administered by intravenous (IV) infusion, every week (Q1W \[± 1days\]) for the first 3 weeks (from the first to the fourth dose), then administered every 2 weeks (Q2W \[± 3 days\]) for all the following doses.
AP203
DrugThe dose-expansion phase will be conducted following completion of dose escalation for AP203. Participants will receive AP203 by IV infusion, administered Q1W (± 1 days) for the first 3 weeks (from the first to the fourth dose), then administered Q2W (± 3 days) for all the following doses, at the RP2D for each expansion cohort.
Dose-Escalation: Number of Participants With Dose Limiting Toxicity (DLT)
DLT is defined as toxicity (adverse event \[AE\] at least possibly related to AP203) occurring during the DLT evaluation period
Both Dose-Escalation and Dose-Expansion: Number of Participants With Adverse Events (AEs) and Serious AEs
Safety assessed using incidence, nature, and severity of AEs and SAEs
Dose-Expansion: Overall response rate(ORR) (assessed by the Investigator according to RECIST version 1.1)
ORR is defined as the proportion of participants with CR or PR
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