Clinical Trials

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). Novartis holds exclusive global rights to 3BP’s FAP-targeting peptide technology, while 3BP retained rights to certain imaging agents and FAP small molecules. The Phase 1/2 LuMIERE study of FAP-2286 sponsored by 3BP’s partner Clovis Oncology is enrolling (NCT04939610). FAP-2286 is an unlicensed medical product.

3BP-4452 / DPI-4452 / Debio 0228 is a clinical candidate under investigation as a PTRT and imaging agent targeting carbonic anhydrase IX (CAIX). Debiopharm International SA holds exclusive worldwide rights to the program. A study to assess safety, tolerability, and efficacy of ¹⁷⁷Lu-DPI-4452 in participants with unresectable locally advanced or metastatic solid tumors is enrolling (NCT05706129). 3BP-4452 / DPI-4452 / Debio 0228 is an unlicensed medicinal product.

Study of ¹⁷⁷Lu-DPI-4452 in Unresectable Locally Advanced or Metastatic Solid Tumors

Summary: The purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of ⁶⁸Ga-DPI-4452; the purpose of Part B is to determine the recommended phase 2 dose (RP2D) for ¹⁷⁷Lu-DPI-4452 for each tumor type; and the purpose of Part C is to evaluate the preliminary antitumor activity of ¹⁷⁷Lu-DPI-4452 as monotherapy.

Study Status: Enrolling

Study Identifier: NCT05706129

3BP-227 / FPI-2059 / IPN01087 is a clinical candidate under investigation as a targeted radionuclide therapy (TRT) and imaging agent targeting neurotensin receptor 1 (NTR1). Fusion Pharmaceuticals holds exclusive worldwide rights to the program. A phase 1 study of ²²⁵Ac-FPI-2059 in adult participants with solid tumours is enrolling (NCT05605522). 3BP-227 / FPI-2059 / IPN01087 is an unlicensed medicinal product.

Study of ²²⁵Ac-FPI-2059 in Adult Participants With Solid Tumours

Summary: This is a first-in-human Phase 1 clinical trial designed to investigate the safety, tolerability, pharmacokinetics, and biodistribution of ²²⁵Ac-FPI-2059 and ¹¹¹In-FPI-2058 in participants with neurotensin receptor 1 (NTSR1)-expressing solid tumours.

Study Status: Enrolling

Study Identifier: NCT05605522