SPLIT Abs
DrugParticipants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
Other names: RO7782304, RO7782306
NCT Number: NCT07416552
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
Other names: RO7782304, RO7782306
Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.
Other names: RO7205834-009
Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.
Other names: RO7205834-010
Time frame: Up to approximately 48 weeks
Time frame: Up to approximately 48 weeks
Time frame: Up to approximately 48 weeks
Time frame: Up to approximately 5 years
Time frame: Up to approximately 48 weeks
Time frame: Up to approximately 48 weeks
Time frame: Up to approximately 48 weeks
Time frame: Up to approximately 48 weeks
Time frame: Baseline, Up to approximately 48 weeks
Time frame: Up to approximately 48 weeks
Time frame: Up to approximately 48 weeks
Time frame: Up to approximately 48 weeks
Time frame: Up to approximately 48 weeks
Time frame: Up to approximately 48 weeks
Time frame: Up to approximately 48 weeks
Contact information is provided by the study sponsor or research team.
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
Reference Study ID Number: BP45930 https://forpatients.roche.com/ No attachments to email below.
CONTACT
888-662-6728 (U.S. and Canada)
Hoffmann-La Roche
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06149481
Colonic Diseases, Colorectal Neoplasms
Bethesda, Maryland, United States
View Trial DetailsNCT01174121
Adnexal Diseases, Breast Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT06820463
Colonic Diseases, Colorectal Neoplasms
Duarte, California, United States
View Trial DetailsNCT05443087
Adenocarcinoma, Carcinoma
Amiens, France
View Trial Details