P=N/A, N=20, Withdrawn, Metro South Health | Not yet recruiting --> Withdrawn

[177Lu]-Lu-6 showed superior tumor retention (13% uptake) and internalization (3.5%) compared to [177Lu]-Lu-FAP-2286/N188, with sustained tumor growth suppression in xenograft models. PET/SPECT imaging revealed high tumor-to-background ratios and favorable pharmacokinetics, highlighting the potential of these agents for clinical application.

[177Lu]Lu-FAPI-46 demonstrated lower therapeutic efficacy, as a monotherapy or in combination with temozolomide, than did [225Ac]Ac-FAPI-46. FAPI-46 demonstrates significant potential as a theranostic agent for glioblastoma in peripheral models. However, its inability to cross the blood-brain barrier in orthotopic models highlights the need for future studies to improve its clinical applicability.

P3, N=210, Not yet recruiting, National Heart, Lung, and Blood Institute (NHLBI)

P1, N=157, Recruiting, Mestag Therapeutics Limited

P2, N=104, Recruiting, AstraZeneca

P1, N=12, Active, not recruiting, AstraZeneca AB | Recruiting --> Active, not recruiting

P1/2, N=98, Completed, BioXcel Therapeutics Inc | Trial completion date: Dec 2024 --> Aug 2025

Talabostat plus pembrolizumab demonstrates preliminary anti-tumor activity in patients with relapsed SCNC. Further evaluation in a randomized study is warranted to assess the contribution of talabostat in this high-risk disease subset.

In NSCLC, fibroblast activation protein (FAP)-targeted agents such as [177Lu]Lu-FAP-2286 demonstrated partial metabolic responses, including a 44.4% response rate and 78% disease control in a mixed cohort...Early efficacy signals exist for strong somatostatin receptor (SSTR)-targeted therapy in SCLC and FAP-targeted therapy in NSCLC, but evidence remains limited. Prospective trials with standardized protocols and dosimetry are needed to define TRT's role in lung cancer treatment.

In summary, treatment with a tumor-targeted CD40 agonist antibody is feasible, clinically manageable and induces immunomodulation of the tumor microenvironment. ClinicalTrials.gov registration: NCT04857138 .

Collectively, these data confirm a favorable safety profile for MP0317 and support further clinical evaluation in combination with complementary immunotherapies. ClinicalTrials.gov registration: NCT05098405 .