A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
* Dose escalation Phase and Dose expansion Phase Inclusion Criteria: 1. Written informed consent by the participants or the participant's legally authorized representative prior to screening. 2. 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. 3. 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. 4. Participants with adequate organ function defined by the following: Participants must not have required blood transfusion or growth factor support ≤ 14 days before sample collection at screening: 1. Absolute neutrophil