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

In mouse lung tumor and human organoid models, MiNK-215 promotes durable, antigen-specific T-cell responses and overcomes resistance to immunotherapy without causing off-target toxicity. See related article by Chantzoura et al., p. XX .

P2, N=75, Recruiting, Centre Hospitalier Universitaire de Besancon | Not yet recruiting --> Recruiting | Trial completion date: Jun 2029 --> Nov 2029 | Initiation date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2028 --> Nov 2028

In our in vitro and in vivo studies, [177Lu]Lu-FAP-2286 and [161Tb]Tb-FAP-2286 demonstrated similar behavior. In the applied PDAC mouse model, FAP-TRT showed limited therapeutic efficacy, most likely due to the limited radiopharmaceutical uptake observed in the tumors. This hampered determination of a potential benefit of either radioisotope for FAP-TRT. Of note, a modest response was observed in the tandem therapy group that first received [177Lu]Lu-FAP-2286, followed by [161Tb]Tb-FAP-2286.

Particularly small molecules (i.e. FAPI-46, FAPI-74) and peptides (i.e. FAP-2286, DOTAGA.SA.FAPi) seem to be some of the most promising molecular probes for imaging and therapy...In contrast, FAP-targeted therapeutics remain in the Phase-I or proof-of-concept stage but brings hope for patients with systemic disease who are left out and urgently need additional innovation drives beyond the standard care. This review article will give insight into the most recent developments in the FAP-Therapeutic applications of cancer treatments using several different promising FAP-derivates to improve FAP-theranostic in oncology.

P1/2, N=100, Recruiting, Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting

P2, N=35, Recruiting, Institut Curie | Trial completion date: Jan 2030 --> Aug 2030 | Trial primary completion date: Jan 2029 --> Aug 2029

P1, N=45, Not yet recruiting, Mayo Clinic

Quantitative parameters derived from [68Ga]Ga-FAP-2286 PET/CT are valuable predictors of [177Lu]Lu-FAP-2286 treatment efficacy in NSCLC patients. Dynamic monitoring of these metrics allows for early identification of treatment responses and supports personalized therapy strategies.