NCT06669975

A Study of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors

A Phase 1/2, Open-label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: AP Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2, multi-regional, multi-center, open-label, first-in-human (FIH), dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of AP402 in HER2-positive patients with locally or advanced solid tumors.

Detailed description

The study will consist of 2 parts: * Part 1 (Dose Escalation): Dose escalation will consist of 7 cohorts where an IV infusion of AP402 will be administered once every 2 weeks to determine the maximum tolerated dose (MTD) (ie, the highest safe dose administered to patients) and the recommended phase 2 dose (RP2D) of AP402. For dose-escalation, an accelerated dose titration design will be utilized for the first 2 dose cohorts, followed by a standard 3+3 dose titration design for the remaining 5 cohorts. Up to 42 patients will be enrolled in Part 1. * Part 2 (Dose Expansion): After the MTD and/or RP2D are determined by the Safety Review Committee (SRC) (see Section 6.5), additional patients will be enrolled in Part 2 and will be treated with AP402 at that dose once every 2 weeks. Part 2 will be based on the Simon's two-stage optimal design (Simon, 1989) and is expected to enroll approximately 43 patients in 1 or 2 selected tumor types. Administration of the IP will continue for 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, intolerable toxicity, withdrawal of consent, study completion, death or other reasons leading to treatment discontinuation, whichever comes first

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	AP402 (Part 1 Dose esclation)	Dose escalation will consist of 7 cohorts where an Intraveous infusion of AP402 will be administered once every 2 weeks to determine the maximum tolerated dose (MTD) (ie, the highest safe dose administered to patients) and the recommended phase 2 dose (RP2D) of AP402.
DRUG	AP402 (Part 2 Dose Expansion)	After the MTD and/or RP2D are determined by the SRC, additional patients will be enrolled in Phase 2 dose expansion and will be treated with AP402 at that dose.

Timeline

• Start date: 2025-04-22
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-11-01
• Last updated: 2025-04-25

Locations

3 sites across 1 country: Australia