RecruitingPhase 1Phase 2NCT05473156

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

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

Sponsor

AP Biosciences Inc.

Enrollment

168 participants

Start Date

Jul 24, 2023

Study Type

INTERVENTIONAL

Conditions

Locally Advanced or Metastatic Solid Tumors

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new experimental drug called AP203 in patients with advanced or metastatic solid tumors (cancers in organs or tissues) that have not responded to existing treatments, to assess its safety and how the body processes it. **You may be eligible if...** - You have an advanced or metastatic solid tumor that has progressed despite standard treatments - Your cancer has at least one measurable lesion on imaging - You are in good enough overall health to participate (ECOG performance status 0–1, life expectancy ≥ 3 months) - Your organ function (blood counts, liver, kidneys) meets the required levels **You may NOT be eligible if...** - You have uncontrolled brain metastases (cancer spread to the brain) - You have serious active infections or autoimmune diseases requiring systemic treatment - You have significant heart disease or active bleeding - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAP203

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.

DRUGAP203

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.