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
Summary
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.
Arms & interventions
- DrugSPLIT Abs
Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
- Drug203Pb-DOTAM
Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.
- Drug212Pb-DOTAM
Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.
Outcome measures
Primary
Part 1: Serum Concentration of SPLIT Abs
Time frame: Up to approximately 48 weeks
Part 1: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM
Time frame: Up to approximately 48 weeks
Part 1 to 2: Absorbed Radiation Dose of 212Pb-DOTAM extrapolated from 203Pb-DOTAM
Time frame: Up to approximately 48 weeks
Part 1 to 3: Percentage of Participants With Adverse Events (AE)
Time frame: Up to approximately 5 years
Secondary
Part 1 to 2: Uptake of 203Pb-DOTAM in Tumor and Normal Tissue
Time frame: Up to approximately 48 weeks
Part 1 to 2: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM
Time frame: Up to approximately 48 weeks
Part 1 to 3: Serum Concentration of CEA-PRIT 2.0
Time frame: Up to approximately 48 weeks
Part 1 to 3: Time Course of Blood and Plasma Radioactivity for 212Pb-DOTAM
Time frame: Up to approximately 48 weeks
Part 1 to 3: Percentage of Participants With Anti-Drug Antibodies (ADAs) Against SPLIT Abs
Time frame: Baseline, Up to approximately 48 weeks
Part 1 to 3: Objective Response Rate (ORR)
Time frame: Up to approximately 48 weeks
Part 1 to 3: Disease Control Rate (DCR)
Time frame: Up to approximately 48 weeks
Part 1 to 3: Duration of Response (DOR)
Time frame: Up to approximately 48 weeks
Part 1 to 3: Progression-Free Survival (PFS)
Time frame: Up to approximately 48 weeks
Part 1 to 3: Overall Survival (OS)
Time frame: Up to approximately 48 weeks
Part 1 to 3: Correlation Between Carcinoembryogenic Antigen (CEA) Tumor Expression and Clinical Activity
Time frame: Up to approximately 48 weeks
Eligibility criteria
Study locations (1)
Nebraska Cancer Specialists
Omaha, Nebraska, 68130