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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.
Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.
Nebraska Cancer Specialists
Omaha, Nebraska, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGUniv of Wisconsin-Madison
Madison, Wisconsin, United States
RECRUITINGPart 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
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
Reference Study ID Number: BP45930 https://forpatients.roche.com/ No attachments to email below.
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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