drugset / Trial / NCT05496686
Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma
Phase 1
Active not recruiting
16 enrolled
Modulation Therapeutics, Inc.
H. Lee Moffitt Cancer Center and Research Institute · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The primary aim of the study is to establish the maximum-tolerated dose (MTD) of 225Ac-MTI-201 in participants with metastatic uveal melanoma. The secondary aims are to describe the pharmacokinetics of 225Ac-MTI-201 and the toxic effects of 225Ac-MTI-201 in participants with metastatic uveal melanoma.
Timeline
- Start
- 2022-07-21
- Primary completion
- 2027-03-31
- Completion
- 2029-02-25
Publications
- Background Tafreshi NK, Doligalski ML, Tichacek CJ, Pandya DN, Budzevich MM, El-Haddad G, Khushalani NI, Moros EG, McLaughlin ML, Wadas TJ, Morse DL. Development of Targeted Alpha Particle Therapy for Solid Tumors. Molecules. 2019 Nov 26;24(23):4314. doi: 10.3390/molecules24234314.
- Background Tafreshi NK, Tichacek CJ, Pandya DN, Doligalski ML, Budzevich MM, Kil H, Bhatt NB, Kock ND, Messina JL, Ruiz EE, Delva NC, Weaver A, Gibbons WR, Boulware DC, Khushalani NI, El-Haddad G, Triozzi PL, Moros EG, McLaughlin ML, Wadas TJ, Morse DL. Melanocortin 1 Receptor-Targeted alpha-Particle Therapy for Metastatic Uveal Melanoma. J Nucl Med. 2019 Aug;60(8):1124-1133. doi: 10.2967/jnumed.118.217240. Epub 2019 Feb 7.
- Background Tafreshi NK, Kil H, Pandya DN, Tichacek CJ, Doligalski ML, Budzevich MM, Delva NC, Langsen ML, Vallas JA, Boulware DC, Engelman RW, Gage KL, Moros EG, Wadas TJ, McLaughlin ML, Morse DL. Lipophilicity Determines Routes of Uptake and Clearance, and Toxicity of an Alpha-Particle-Emitting Peptide Receptor Radiotherapy. ACS Pharmacol Transl Sci. 2021 Mar 12;4(2):953-965. doi: 10.1021/acsptsci.1c00035. eCollection 2021 Apr 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 225Ac-MTI-201 | Unknown | 4.7 unknown | Intravenous |
| Subject | 225Ac-MTI-201 | Unknown | 9.5 unknown | Intravenous |
| Subject | 225Ac-MTI-201 | Unknown | 19 unknown | Intravenous |
| Subject | 225Ac-MTI-201 | Unknown | 38 unknown | Intravenous |
| Subject | 225Ac-MTI-201 | Unknown | 76 unknown | Intravenous |
| Subject | 225Ac-MTI-201 | Unknown | 152 unknown | Intravenous |
| Subject | 225Ac-MTI-201 | Unknown | 254 unknown | Intravenous |
| Subject | 225Ac-MTI-201 | Unknown | 424 unknown | Intravenous |
| Subject | 225Ac-MTI-201 | Unknown | 564 unknown | Intravenous |
| Subject | 225Ac-MTI-201 | Unknown | 750 unknown | Intravenous |
| Subject | 225Ac-MTI-201 | Unknown | 998 unknown | Intravenous |
| Subject | 225Ac-MTI-201 | Unknown | 1327 unknown | Intravenous |