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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

NCT05473156 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-03-26

No results posted yet for this study

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.

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)

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.

Sponsors & Collaborators

  • AP Biosciences Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-24
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05473156 on ClinicalTrials.gov