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RECRUITING
NCT05473156
PHASE1/PHASE2

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

Sponsor: AP Biosciences Inc.

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.

Official title: A Phase 1/2, Open-label Study of the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2023-07-24

Completion Date

2027-12

Last Updated

2025-03-26

Healthy Volunteers

No

Interventions

DRUG

AP203

Eight 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.

DRUG

AP203

The 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.

Locations (1)

AP Biosciences Inc.

Taipei, Taiwan