P3, N=430, Recruiting, Telix Pharmaceuticals (Innovations) Pty Limited | Not yet recruiting --> Recruiting

The prototype molecular theranostic is the 68Ga/177Lu DOTATATE pair that targets somatostatin receptor subtype 2 in neuroendocrine tumors...Despite challenges and limitations, molecular theranostics is a powerful tool in the precision medicine landscape. Molecular theranostics is a vehicle for improved outcomes in cancer patients with a future-facing portfolio of opportunities.

P1, N=24, Active, not recruiting, POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company | N=10 --> 24

P3, N=439, Active, not recruiting, Curium US LLC | Trial completion date: Jun 2029 --> Feb 2029

We developed a novel and long-acting radiotherapeutic agent 177Lu-AB-3PRGD2, and pioneered a strategy guided by PD-L1-targeted nuclear medicine imaging for the combination of TRT and ICB towards precision cancer therapy, optimizing the therapeutic efficacy and reducing the cost and potential toxicity risks. This strategy could also be adapted for clinical practice, combining conventional radiotherapy or chemotherapy with ICB to enhance therapeutic efficacy.

P1, N=6, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=116 --> 6

P2, N=58, Active, not recruiting, Radboud University Medical Center | Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Mar 2025

P2, N=35, Not yet recruiting, Institut Curie

P1/2, N=0, Withdrawn, University of Chicago | N=52 --> 0 | Trial completion date: Feb 2027 --> Sep 2024 | Recruiting --> Withdrawn | Trial primary completion date: Feb 2027 --> Sep 2024

P3, N=1145, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting

Question Peptide receptor radionuclide therapy is utilised for patients with somatostatin receptor-positive well-differentiated neuroendocrine tumours; however, prognostic predictors are not well established. Findings Progression-free survival was significantly associated with the proportional change in whole tumour volume and total receptor expression between basal and interim [68Ga]Ga-DOTA-TOC PET/CT. Clinical relevance Interim [68Ga]Ga-DOTA-TOC PET/CT can serve as a valuable imaging method to predict prognosis of peptide receptor radionuclide therapy.

P2, N=30, Recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025

P1, N=67, Recruiting, Theragnostics Ltd

P1, N=48, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2026 --> Aug 2031

P2, N=25, Recruiting, Fundación de investigación HM | Not yet recruiting --> Recruiting

PRRT utilizes [177Lu]Lu-DOTA-TATE to target the SSR receptor and can significantly prolong progression-free survival in patients with advanced, progressive neuroendocrine tumor of the gastroenteropancreatic system (GEP-NET)...Variable follow-up intervals are recommended for NET G1 and G2. Tumors with higher proliferation rates or advanced metastatic disease necessitate more frequent assessments.

P1, N=10, Recruiting, University of Wisconsin, Madison | Not yet recruiting --> Recruiting

P2, N=474, Not yet recruiting, Alliance for Clinical Trials in Oncology

P2, N=10, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Initiation date: Sep 2024 --> Dec 2024

P=N/A, N=80, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Initiation date: Sep 2024 --> Dec 2024

18F-FDOPA PET/CT was found to be the superior functional imaging modality, with 100% lesion detection rate when compared to that of 68Ga-DOTATATE, 18F-FDG, 18F-FDA, and 123I-MIBG scans. While patients did not respond to chemotherapy or tyrosine kinase inhibitors, they responded to targeted radiotherapy using high-specific-activity 131I-MIBG (Azedra®) or 177Lu-DOTATATE (Lutathera®).

P2, N=93, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Sep 2025 --> Sep 2033 | Trial primary completion date: Sep 2024 --> Sep 2032

P1, N=124, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting

Upon enrollment, the patient received two rounds of the radiolabeled somatostatin analogue lutetium-177 octreotate (177Lu-DOTATATE), which was well tolerated...The observed variation in SSTR2 expression between tumor lesions suggests that heterogeneous target expression may have been the reason for treatment failure in this patient's case. Further investigation within the LuDO-N trial will give a more comprehensive understanding of the correlation between SSTR2 expression levels and treatment outcomes, which will be important to advance treatment strategies based on MRT for children with high-risk NB.

P=N/A, N=11, Not yet recruiting, Central Hospital, Nancy, France

P=N/A, N=25, Not yet recruiting, Central Hospital, Nancy, France | Trial completion date: Jul 2024 --> Mar 2025 | Initiation date: Jul 2024 --> Nov 2024 | Trial primary completion date: Jul 2024 --> Jan 2025

P=N/A, N=80, Not yet recruiting, Central Hospital, Nancy, France | Initiation date: Sep 2024 --> Jan 2025

P1, N=35, Recruiting, Full-Life Technologies GmbH | Not yet recruiting --> Recruiting | Initiation date: Jul 2024 --> Oct 2024

P2, N=25, Not yet recruiting, Fundación de investigación HM

Recent approvals and ongoing investigations of single agents and intensification approaches will keep transforming the mCRPC treatment landscape. Improvement of patient profiling applying recognized genomic, molecular, and clinical predictive and prognostic indicators is fundamental to optimize sequential use of available therapies.

Artificial-intelligence-based analysis of baseline PSMA PET/CT images may improve patient selection. Validation of these findings on larger cohorts is warranted.

P1, N=96, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting

P1, N=6, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025

P3, N=1126, Recruiting, Novartis Pharmaceuticals | Active, not recruiting --> Recruiting

P2, N=120, Active, not recruiting, Cellectar Biosciences, Inc. | Trial completion date: Jun 2025 --> Dec 2026 | Recruiting --> Active, not recruiting

P2, N=80, Recruiting, Novartis Pharmaceuticals | Trial completion date: Nov 2028 --> Apr 2026

P1/2, N=30, Recruiting, The First Affiliated Hospital of Xiamen University | Phase classification: P1 --> P1/2 | N=20 --> 30

P2, N=618, Active, not recruiting, Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori | Unknown status --> Active, not recruiting | Trial completion date: May 2021 --> Jan 2025 | Trial primary completion date: May 2021 --> Jan 2025

P1, N=10, Recruiting, Stanford University | Trial primary completion date: Mar 2024 --> Mar 2025

P2, N=130, Recruiting, National Cancer Institute (NCI) | N=90 --> 130

Carcinoid crisis is a rare but potentially life-threatening complication of Lutetium-177-Dotatate therapy. Knowledge of risk factors and prompt recognition of symptoms is essential to successful treatment, with early initiation of intravenous octreotide serving a critical step in reducing morbidity of this adverse event.

177Lu-OncoFAP and 177Lu-FAP-2286 were included in the biodistribution study as controls. OncoFAP-23 presents enhanced tumor uptake and tumor retention and low accumulation in healthy organs, findings that correspond to a strongly improved in vivo antitumor efficacy. The data presented in this work support the clinical development of 177Lu-OncoFAP-23 for the treatment of FAP-positive solid tumors.