AP Biosciences has dosed the first patient in a Phase 1 trial of AP402, a novel T cell engager targeting p95HER2, a truncated form of HER2 present in a significant portion of HER2-positive cancers and linked to poor prognosis. The trial, taking place in Australia with potential expansion to other regions, will assess AP402’s safety, tolerability, and preliminary efficacy in patients with advanced solid tumors, including breast cancer, who have relapsed or are refractory to existing anti-HER2 treatments. This is the only T-cell engager in human trials targeting p95HER2, representing a new approach to treating these difficult-to-treat cancers.
This development is crucial for patients with HER2-positive cancers who have exhausted standard treatment options. Current HER2 therapies do not effectively target p95HER2, leaving a significant patient population with limited recourse. AP402’s unique mechanism, bridging activated T cells and p95HER2-expressing cancer cells within the tumor, offers the potential for a potent, targeted immune response while minimizing systemic toxicity, a common challenge with current immunotherapies. This targeted approach could significantly improve outcomes for these patients and address an unmet medical need.
The AP402-101 trial is a multi-center, open-label study aiming to enroll up to 85 patients. It will involve a dose-escalation phase to determine the maximum tolerated dose and recommended Phase 2 dose, followed by a dose-expansion phase focused on specific HER2-positive tumor types. The study will primarily assess safety and tolerability, with secondary endpoints including objective response rate, disease control rate, and pharmacokinetic parameters. Preclinical data supporting AP402’s potential will be presented at the American Association of Cancer Research (AACR) conference.
The commencement of this Phase 1 trial is a significant step forward in the development of targeted therapies for resistant HER2-positive cancers. Positive results from this trial could lead to a new treatment option for patients with limited alternatives and potentially reshape the treatment landscape for this aggressive form of cancer. The data presented at the AACR conference will be a key indicator of AP402’s potential and will be closely watched by the oncology community.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
