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Clinical Trial · NCT05283330
A Phase 1/2a open-label, first-in-human, dose escalation and expansion study to determine the safety, tolerability, dosimetry, pharmacokinetics, and preliminary efficacy of 212Pb-DOTAM-GRPR1 in adult participants with recurrent or metastatic GRPR-expressing tumors
Overview
This is a first-in-human (FiH), open-label study consisting of dose escalation and dose expansion parts to evaluate the safety, tolerability, pharmacokinetics (PK), dosimetry, and preliminary antitumor activity of 212Pb-DOTAM-GRPR1 in adult participants with advanced GRPR-expressing solid tumors.
Sponsor
OranomedPhase
Phase 1/2
Contacts
Jason D Hurt, MD
jason.hurt@oranomed.com
4696380744
ClinicalTrials.gov
NCT05283330Drug / Compound
²¹²Pb-DOTAM-GRPR1
Isotope(s):
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
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