Clinical Trial

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

Study acronym: APT-CUBE
Recruiting Phase 1/2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-07-21; most recent amendment 2025-03-23.
Status change: Not Yet Recruiting → Recruiting 2025-03-23
Trial Details
NCT Number NCT05473156
Lead Sponsor AP Biosciences Inc.
Conditions Locally Advanced or Metastatic Solid Tumors, Non Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC), Esophageal Squamous Cell Carcinoma (ESCC)
Enrollment 168 participants
Start Date 2023-07-24
Primary Completion 2026-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-03-26