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:

Oranomed

Contacts:

Jason D Hurt, MD

jason.hurt@oranomed.com

4696380744

Government Study Link:

NCT05283330 - Click here to see study on

ClinicalTrials.gov

Drug Details

²¹²Pb-DOTAM-GRPR1
Isotopes:
    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
  • LEAD-212
Target: GRPR
Chelator: DOTAM