P1, N=410, Recruiting, Karolinska University Hospital | Not yet recruiting --> Recruiting

[177Lu]Lu-RTX-2358 demonstrated a manageable safety profile in a series of patients who were heavily pretreated for their disease. Given a promising therapeutic index as a result of prolonged retention in tumors and clearance from normal organs, further clinical evaluation is warranted.

P1, N=56, Recruiting, 3B Pharmaceuticals GmbH | Not yet recruiting --> Recruiting

Various FAPI radiotracers, including FAPI-04, FAPI-46, and FAP-2286, offer unique pharmacokinetic properties...However, challenges remain, including FAP expression heterogeneity and the need for optimized treatment protocols. The aim of this review is to provide a comprehensive overview of the current evidence and future directions of FAPI-based theranostics in sarcoma management, highlighting its potential to improve patient outcomes.

P1/2, N=36, Recruiting, Novartis Pharma AG

A therapy experiment in immunocompetent mice bearing low FAP-expressing tumors showed that the combination with L19-hIL2 potentiated the antitumoral activity of 177Lu-OncoFAP-23 and OncoFAP-GlyPro-MMAE. These results provided the motivation for the clinical development of these combinations for treating FAP-positive solid tumors.

P1, N=149, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting | Trial completion date: May 2028 --> Feb 2028

P1, N=45, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting

P1, N=132, Recruiting, Chengdu New Radiomedicine Technology Co. LTD. | Not yet recruiting --> Recruiting | Initiation date: Jul 2025 --> Nov 2025

Therapeutic evidence shows encouraging tumour retention and safety profiles for agents such as [177Lu]Lu-FAP-2286 and [90Y]Y-FAPI-46, while α-emitting radiotracers (e.g., [225Ac]Ac-FAPI-04) demonstrate potent antitumor effects in preclinical models...Nonetheless, clinical evidence remains in its early stages, and substantial questions persist regarding dosimetry, intertumoral variability in FAP expression, and optimal ligand selection for therapy. Continued development of next-generation FAPI constructs, along with well-designed prospective trials, will be crucial in defining the future role of FAPI-based theranostics in oncology.

This study provides real-world evidence supporting FAP-targeted radiopharmaceutical therapy as a treatment option for this patient population and suggests FAP-based imaging is useful for response monitoring. Larger, prospective studies are warranted to confirm these findings.

P=N/A, N=60, Recruiting, Tata Memorial Centre