225Ac-3BP-3940 / 3B Pharma, Curanosticum - LARVOL DELTA

Bladder RadioMolecularIncubator Theranostics: Safety and Efficacy of Intravesical 177Lu-FAP (3BP-3940) and 177Lu-CXCR4 and Systemic 177Lu/225Ac-3BP-3940 in High-Grade Muscle-Invasive Bladder Cancer (SNMMI 2026) - "Histologies ranged from conventional urothelial carcinoma to poorly differentiated locally advanced, plasmacytoid variant, or metastatic (lymph nodal, peritoneal, osseous); prior treatments: TURBT (all), platinum CHT (all), pembrolizumab (2 patients), and sacituzumab govitecan (1 patient). This study highlights the feasibility and preliminary efficacy of CXCR4- and FAP-targeted radioligand therapy in refractory bladder cancer, leveraging tumor stroma for precision delivery. Intravesical RLT exploits the bladder's "radioincubator" potential for precise, high-dose tumor irradiation with limited off-target effects and addresses anatomical constraints, while extension to FAP/CXCR4 dual targeting and alpha/beta tandem RLT may enhance efficacy in selected patients with disseminated disease. This real-world experience demonstrates favorable tolerability and promising early signals of efficacy, with improvements in quality of life and a potential new option for..."

Clinical • IO biomarker • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Thrombosis • Urothelial Cancer • CXCR4 • FAP

Fibroblast Activation Protein-Targeted Radiopharmaceutical Therapy Using 177Lu-, 90Y-, and 225Ac-Labeled 3BP-3940: First Experience in 21 Different Advanced Malignancies. (PubMed, J Nucl Med) - " Administrations of [177Lu]Lu-, [90Y]Y-, and [225Ac]Ac-3BP-3940 were well tolerated, and most adverse events were mild (pain 16%, pain flare 13%, nausea 13%, vomiting 7%, partial alopecia 8%, intensified fatigue 5%, diarrhea 3%, headache 2%, and transient fever 5%)...The observed survival benefit appears to be highly promising. Further prospective randomized analysis in a larger cohort with longer follow-up is warranted."

First-in-human • Journal • Alopecia • Fatigue • Immunology • Oncology • Pain • Pancreatic Cancer • Sarcoma • Solid Tumor

Novel FAP-Targeted Radiopharmaceutical Therapy with 177Lu / 90Y / 225Ac-3BP-3940 in Patients with Pancreatic Ductal Adenocarcinoma (PDAC) (SNMMI 2026) - "FAP-targeted radiopharmaceutical therapy with 177Lu-/90Y-/225Ac-labeled 3BP-3940 is feasible and shows an acceptable safety profile in heavily pretreated patients with metastatic PDAC. The therapy achieved high tumor uptake with limited off-target exposure and produced encouraging molecular imaging responses in a subset of patients. These first-in-human findings provide a rationale for further prospective evaluation of 3BP-3940 FRT in larger, controlled clinical studies."

Clinical • First-in-human • Alopecia • Immunology • Oncology • Pancreatic Ductal Adenocarcinoma • FAP

New Radiopharmaceutical frontiers after treatment failure in Neuroendocrine Carcinoma: Actinium-225 Alpha Therapy, FAP Targeting and SSTR Antagonists (SNMMI 2026) - "Prior therapies included chemotherapy (n = 6), radiotherapy (n = 5), surgery (n = 4), somatostatin analogues (n = 3), everolimus (n = 1) and 177Lu-DOTATATE PRRT (n = 2)...Four patients received FRT with 3BP-3940: one received one cycle of 90Y-3BP-3940; one received one tandem cycle of 225Ac/177Lu-3BP-3940; one received two cycles of 177Lu-3BP-3940 and one cycle of 90Y-3BP-3940; one received one cycle of 225Ac-3BP-3940 followed by three tandem cycles of 225Ac/177Lu-3BP-3940... In this small, heavily pretreated cohort of patients with advanced NEC, salvage RPT using alpha emitters, FAP-targeted therapy and SSTR agonist- and antagonist-based PRRT was feasible and overall well tolerated, but response rates were low. These preliminary findings support further investigation aimed at improving efficacy, including exploration of combinations with other therapeutic strategies."

Endocrine Cancer • Hepatocellular Cancer • Leukopenia • Neuroendocrine Carcinoma • Neuroendocrine Neoplasm • Oncology • Solid Tumor • Thrombocytopenia • SSTR

Augmenting FAP-Directed Radioligand Therapy with Chemotherapy and Metabolic Radiosensitization in Metastatic Pancreatic Adenocarcinoma: A Case Report (SNMMI 2026) - "This case report of mPDAC treated with a truly multimodal theranostic concept - intensive NALIRIFOX chemotherapy combined with sequential FAP-directed radioligand therapy (90Y, 177Lu, 225Ac-3BP-3940) under metabolic radiosensitization with B-OT - demonstrated excellent feasibility and tolerability in clinical practice. The impressive, deep, and durable response documented by serial FAP PET and a >99% decline with normalization of CA 19-9, together with preserved performance status and quality of life over one year, strongly suggests a clinically meaningful synergistic effect. These results encourage further prospective evaluation of this combination strategy as a promising new treatment paradigm for patients with mPDAC."

Case report • Clinical • Metastases • Alopecia • Immunology • Mucositis • Oncology • Pancreatic Adenocarcinoma • Pancreatic Ductal Adenocarcinoma

FAP-directed Radiopharmaceutical Therapy in metastatic gastrointestinal carcinoma as rescue therapy after failure of conventional treatments: A retrospective analysis on safety, efficacy and survival (EANM 2025) - "Previous treatments: chemotherapy (96%); surgery of primary (61%); external beam radiation therapt of primary or metastases (61%); therapy with Bevacizumab (56%); surgery of metastases (35%); ICPi (39%); TKi (39%). 65 FRT cycles were totally administered over 48 months (monotherapies: thirty-six 177Lu-3BP-3940, eight 90Y-3BP-3940, three 225Ac-3BP-3940; TANDEM: fifteen 225Ac/177Lu-3BP-3940, three 225Ac/90Y-3BP-3940)...At analysis, 8 patients were alive (follow-up: 2-27 months) and 15 had died (survival: 3 days-15 months). Conclusion FRT with radiolabelled-3BP-3940 is overall safe for patients with advanced GI carcinoma. Considering its palliative purpose , both therapy response and survival were encouraging , but larger, prospective trials are needed to improve clinical outcome."

Metastases • Retrospective data • Anal Carcinoma • Anemia • Biliary Cancer • Cholangiocarcinoma • Chronic Kidney Disease • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Leukopenia • Nephrology • Oncology • Renal Disease • Solid Tumor • Thrombocytopenia • FAP

Radiopharmaceutical Therapy in Neuroendocrine Carcinoma using Actinium-225, FAP-targeting, and somatostatin receptor antagonists: A new therapeutic perspective in patients progressing to standard therapies (EANM 2025) - "Previous treatments: CHT (n=5); EBRT (n=4); surgery (n=3); SST analogues (n=2); Everolimus (n=1); 177Lu-DOTATATE (n=1)...Four patients received FRT as follows: one cycle of 90Y-3BP-3940; one cycle of 225Ac/177Lu-3BP-3940 (TANDEM); two cycles of 177Lu-3BP-3940 and one of 90Y-3BP-3940; one cycle of 225Ac-3BP-3940 and three of 225Ac/177Lu-3BP-3940 (TANDEM)...At analysis, 5 patients had died, 1 patient was alive. Conclusion Our experience shows that RPT can offer a therapeutic chance in patients with advanced NEC exhausting other treatments , however response rates were low; further research is needed to enhance RPT efficacy, also exploring the synergistic effects of combination with other therapeutic strategies."

Clinical • Anemia • Endocrine Cancer • Hematological Disorders • Hepatocellular Cancer • Leukopenia • Neuroendocrine Carcinoma • Oncology • Pancreatic Cancer • Solid Tumor • Thrombocytopenia • SSTR

Novel FAP-Targeted Radiopharmaceutical Therapy with 177 Lu/ 90 Y/ 225 Ac-3BP-3940 in Patients with Pancreatic Ductal Adenocarcinoma (PDAC) (EANM 2025) - No abstract available

Clinical • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Targeting metastatic breast cancer with Actinium-225 FAP-directed radiopharmaceutical therapy: a retrospective analysis of safety, efficacy and survival (SNMMI 2025) - "Hydration was provided during and after each cycle; premedication (antiemetics and/or dexamethasone) was given in selected cases...Previous treatments included chemotherapy 100%; surgery of the primary tumor 89%; hormonal therapy 78%; loco-regional radiotherapy 56%; therapy with Denosumab, Bevacizumab and PARP inhibitors (33%, respectively); immune-checkpoint inhibitors 22%; Trastuzumab 22%; β-FRT 22%... Despite the limited sample size and retrospective nature of this study, α-FRT with 225Ac-3BP-3940 appears to be a well-tolerated and effective treatment for metastatic BCa with otherwise limited therapeutic options. Its favorable safety profile and encouraging survival outcomes (up to nearly two years) support its potential role in advanced BCa, warranting further investigation through larger, prospective clinical trials."

Metastases • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pain • Palliative care • Solid Tumor • Triple Negative Breast Cancer • BRCA • BRCA1 • BRCA2 • FAP • HER-2

FAP-Targeted Radiopharmaceutical Therapy using 177Lu-, 90Y- and 225Ac-labeled 3BP-3940 in a Cohort of 88 Patients with 21 Different Advanced Malignancies (SNMMI 2025) - "Administrations of 177Lu-/90Y-/225Ac-3BP-3940 (with cumulative administered radioactivity per patient and range of 177Lu, 17.4 ± 13.0 GBq; 90Y, 6.9 ± 3.9 GBq; and 225Ac 13.4 ± 10.0 MBq) were in general well tolerated. Pain was observed in 11/88 patients (16%) including pain flare in 9/88 (13%), nausea in 11/88 (13%), vomiting in 6/88 (7%), headache in 2/88 (2%), diarrhea 3/88 (3%), a temporary rise in body temperature for one day in 4/88 (2%), partial alopecia (hair loss) in 7/88 (8%), and intensified fatigue in 4/88 patients (7%); no other clinically relevant adverse symptoms or clinically detectable pharmacologic effects were noticed or reported in any of the patients. Dosimetry was calculated for one pancreatic cancer patient who received 9.73 GBq 177Lu-3BP-3940: absorbed radiation doses were as follows: brain 37 mGy, lungs 168 mGy, healthy liver tissue 86 mGy, pancreas 142 mGy, kidneys 265 mGy, and 2200 mGy for the primary pancreatic adenocarcinoma."

Clinical • Metastases • Alopecia • Fatigue • Immunology • Oncology • Pain • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor

FAP-directed radiopharmaceutical therapy of metastatic pancreas adenocarcinoma with alpha-emitting Actinium-225 or in TANDEM (remote) (SNMMI 2025) - "Therapy was performed with palliative purpose and all patients signed informed consent; premedication with antiemetics and/or dexamethasone was administered in selected cases. Our retrospective analysis shows that α-FRT with 225Ac-3BP-3940 (both as monotherapy and in TANDEM with β-emitters) in metastatic PDAC patients who have exhausted conventional therapies is a valuable treatment possibility, showing good safety with acceptable acute adverse events (transient) and long-term toxicity (mainly of mild grade; the only two cases of liver impairment at G3 level occurred in patients with hepatic metastases and pre-FRT hepatic function alterations). α-FRT achieved promising outcomes, with 27% partial remissions and survival extending beyond one year from the first 225Ac-3BP-3940 administration, highlighting its potential in aggressive, treatment-resistant and rapidly progressive PDAC."

Metastases • Anemia • Hematological Disorders • Hepatocellular Cancer • Hepatology • Leukopenia • Liver Failure • Oncology • Pain • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Thrombocytopenia • FAP

A retrospective analysis of safety, efficacy and survival of metastatic colorectal cancer patients treated with Actinium-225 FAP-directed radiopharmaceutical therapy (remote) (SNMMI 2025) - "Premedication (antiemetics/dexamethasone) was administered as needed... We studied 7 males and 3 females (age range 40-75 years at the time of the first α-FRT), previously treated with chemotherapy 100%; surgery of the primary 80%; surgery of metastases 60% (mainly in the liver, 40%); immunotherapy with Bevacizumab 90%; radiotherapy of the primary or metastases 60%; immune-checkpoint inhibitors 30%; β-FRT 50%... Our retrospective analysis shows that α-FRT as monotherapy with 225Ac-3BP-3940 or in TANDEM with β-emitters is a safe treatment option for patients with metastatic progressive CRC, without significant acute adverse events or long-term nephrotoxicity and with manageable long-term hematological toxicity; hepatotoxicity G2/G3 was documented in two patients with hepatic metastases. Considering the palliative purpose of 225Ac-3BP-3940 FRT in a metastatic advanced setting, both therapy response and survival outcomes were overall encouraging. Larger, prospective..."

Metastases • Retrospective data • Anemia • Colorectal Cancer • Fatigue • Hematological Disorders • Hepatocellular Cancer • Leukopenia • Oncology • Pain • Solid Tumor • FAP