Study Title
A Phase 1 Open-Label Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, and Preliminary Efficacy of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors
Study Details
Description:
A Phase 1 SAD/MAD dose escalation and expansion study to determine the safety and effectiveness of ²¹²Pb-DOTAM-GRPR1 in subjects with various GRPR-expressing Tumors
Sponsor:
OranomedContacts:
Jason D Hurt, MDjason.hurt@oranomed.com
4696380744
Government Study Link:
NCT05283330 - Click here to see study onClinicalTrials.gov
Drug Details
²¹²Pb-DOTAM-GRPR1
Isotope(s):
- LEAD-212
LEAD-212
Radioisotope: Pb-212
Theranostic Role: Therapeutic Agent
T1/2 (Half-Life): 10.6 Hours
Decay Mode: ALPHA, BETA, GAMMA
Energy: Alpha 6 MeV (25%), 6 MeV (10%), 8.7 MeV (71%) Beta 1.5 MeV (18%), 1.8 MeV (20%), 2.2 MeV (53%) Gamma 583 keV (30%), 2.6 MeV (36%)
Range: 50-100 micrometers
Decay Daughters: Bi212, Tl208, Po212, Pb208
Status: Clinical Trials Only, 2024 FDA Breakthrough Therapy Designation for ALPHAMEDIX™ GEP-NET Tumors
Target(s):
- GRPR
Chelator: DOTAM
Patient Education
Patient Education Not Yet Provided
Publications
Publications Not Yet Provided
Locations
Not yet provided. Contact Jason D Hurt, MD for more information.
4696380744
jason.hurt@oranomed.com
