177Lu-SN201 / Spago Nanomedical - LARVOL DELTA

Spago Nanomedical continues patient recruitment in the phase I/IIa study Tumorad-01 as planned after DMC recommendation (Yahoo Finance) - "Spago Nanomedical AB (publ) announced today that the Data Monitoring Committee (DMC) recommends the ongoing phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201 to continue according to the current study protocol with the recruitment of additional two patients at the current highest dose. The recommendation is based on the analysis of data from all three patient cohorts totaling 10 dosed patients, which demonstrated a continued acceptable safety profile....To date, 10 patients with 8 different tumor types have been dosed across three patient cohorts, including one patient on the highest current dose of 15 MBq/kg. An analysis of dosed patients shows that safety is acceptable and consistent across all patients."

DSMB • Solid Tumor

Spago Nanomedical Proceeds with Increased Dose in the Phase I/IIa study Tumorad-01 (ACCESSWIRE) - "Spago Nanomedical...announced today that the independent Data Monitoring Committee (DMC) recommends a dose increase in the ongoing phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201. The recommendation is based on analysis of data from two patient groups, consisting of six patients with five different cancer types. Both groups show similar acceptable safety profile....The DMC has conducted an analysis based on all available data for the two first patient groups and assesses that the safety profile in the patient groups is satisfactory and recommends to increase the dose in the study and continue the patient recruitment as planned. A total of six patients with five different tumor types have been dosed in the study to date."

DSMB • Solid Tumor

Second Patient Group Successfully Dosed in Spago Nanomedical's Phase I/IIa Study Tumorad-01 (ACCESSWIRE) - "Spago Nanomedical AB...announced that all patients in the second patient group have been dosed according to plan in the company's Phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201....A total of six patients have so far been included and dosed in the study....In August 2024, the company announced that the first patient group in the Phase I part of the study, consisting of three patients, had been successfully treated with at least one dose of 177Lu-SN201. Furthermore, the DMC recommended that the study continue based on an evaluation of all available data. Now the second patient group in the study, consisting of three patients, two men with lung and rectal cancer and one woman with throat cancer, has also been treated with at least one dose/cycle of 177Lu-SN201. The next evaluation by the DMC is thus expected to be presented during the first quarter. In the meantime, recruitment of patients to the study continues."

DSMB • Trial status • Head and Neck Cancer • Lung Cancer • Rectal Cancer

177Lu-SN201 nanoparticle shows superior anti-tumor efficacy over conventional cancer drugs in 4T1 orthotopic model. (PubMed, Invest New Drugs) - "We show with high statistical significance that 177Lu-SN201 is superior at suppressing the tumor growth not only compared to vehicle but also to the commonly used cancer drugs paclitaxel, niraparib, carboplatin, and the combination of the immune checkpoint inhibitors anti PD-1 and anti-CTLA-4. The treatment is reasonably well-tolerated, as indicated by clinical chemistry of liver and renal function through the measurement of glutamate pyruvate alanine aminotransferase, alanine amino transferase, blood urea nitrogen, and creatinine levels in plasma samples, despite some weight loss. Overall, 177Lu-SN201 presents as a promising therapeutic candidate for cancer treatment."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Tumorad: A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: Spago Nanomedical AB

Metastases • New P1/2 trial • Oncology • Solid Tumor