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Clinical Trial · NCT07416552
A Phase I, Open-Label, Escalation and Expansion Study to Evaluate Dosimetry, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CEA-Pre-Targeted 212Pb Therapy in Participants With Metastatic Colorectal Cancer
Overview
This study will evaluate the dosimetry, safety, efficacy, pharmacokinetics (PK), pharmacodynamics and immunogenicity of CEA-PRIT 2.0 in participants with metastatic microsatellite-stable (MSS) mCRC who are intolerant to or have progressed after having received available standard-of-care (SOC) therapies.
Sponsor
Hoffmann-La RochePhase
Phase 1
Contacts
Reference Study ID Number: BP45930
global-roche-genentech-trials@gene.com
888-662-6728
ClinicalTrials.gov
NCT07416552Drug / Compound
212Pb-DOTAM
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):
- SSTR2
203Pb-DOTAM
Isotope(s):
LEAD-203
Radioisotope: Pb-203
Theranostic Role: SPECT Imaging
T1/2 (Half-Life): 52 Hours
Decay Mode: ELECTRON CAPTURE, GAMMA
Energy: Gamma 279keV (81%)
Range: N/A
Decay Daughters: Tl203 (Stable)
Status: Clinical Trials Only
Target(s):
- SSTR2
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