Drugs / 177Lu-DOTA
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05994157 | Apr → Oct 2025 | non-Hodgkin lymphoma | Y-mAbs Therapeutics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05130255 | Nov 2022 → Mar 2026 | melanoma, neuroblastoma, sarcoma, small cell lung carcinoma | Y-mAbs Therapeutics | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-05-28 | Y-mAbs Therapeutics | Results Y-mAbs Hosts Virtual Radiopharmaceutical R&D Update Highlighting Clinical Progress and Expanded Pipeline ymabs.com ↗
Part A of Trial 1001 demonstrated positive tumor uptake and quantifiable absorbed dose to the tumor at 30 mCi. |
| 2024-09-06 | Orphan Australia | Results Y-mAbs Presents Neuroblastoma Research on Naxitamab and SADA PRIT Technology Platform at AACR Special Conference on Advances in Pediatric Cancer Research serb.com ↗
In a preclinical model of neuroblastoma, also presented in the poster, the chelated radioisotope is administered during the second step of PRIT and binds to GD2-SADA on tumor cells, delivering cytotoxic radiation with minimal off-target exposure. |
| 2021-09-14 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory FDA Approves Phase II Kidney Cancer Therapy Study telixpharma.com ↗
Telix is pleased to announce that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) Application to undertake a clinical study of the Company’s investigational kidney cancer therapy, TLX250 (177Lu-DOTA-girentuximab). |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-05-28 | Y-mAbs Therapeutics | Y-mAbs Hosts Virtual Radiopharmaceutical R&D Update Highlighting Clinical Progress and Expanded Pipeline ymabs.com ↗ |
| 2024-09-06 | Orphan Australia | Y-mAbs Presents Neuroblastoma Research on Naxitamab and SADA PRIT Technology Platform at AACR Special Conference on Advances in Pediatric Cancer Research serb.com ↗ |
| 2021-09-14 | Telix Pharmaceuticals (Innovations) Pty Limited | FDA Approves Phase II Kidney Cancer Therapy Study telixpharma.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 177Lu-DOTA | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05994157 ↗ |
| Route | Intravenous | “GD2-SADA IV at 0.3 mg/kg followed by 30 mCi 177Lu-DOTA IV” NCT05130255 ↗ |