A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)
ConditionMetastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche
About this trial
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.
Eligibility criteria
Qualifiers
Histologically confirmed adenocarcinoma originating from the colon or rectum
Metastatic disease (Stage IV American Joint Committee on Cancer, Version 7)
Confirmed MSS and/or proficient mismatch repair (MMR) status
Experienced disease progression during or within 3 months following the last administration of systemic anti-cancer therapies for metastatic disease
Disqualifiers
Pregnant or breastfeeding or intending to become pregnant
Participants with active central nervous system (CNS) metastases
History of malignancy other than the one under investigation
Any unresolved toxicities from prior therapy, i.e., radiotherapy, chemotherapy, targeted therapy or surgical procedure
Trial design
Treatments tested in this trial
- SPLIT Abs
- 203Pb-DOTAM
- 212Pb-DOTAM
Treatment groups
180 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov