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Recruiting
NCT07416552
A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)
Conditions: Metastatic Colorectal Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 180
Sponsor: Hoffmann-La Roche
Location: Nebraska Cancer Specialists Omaha Nebraska
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.
Eligibility Criteria
Inclusion Criteria:
* 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
* Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Life expectancy estimated by the Investigator to be \>=12 weeks
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
* Adequate cardiovascular, hematological and renal function and laboratory parameters
Exclusion Criteria:
* 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
* Major surgery or significant traumatic injury \
Source: ClinicalTrials.gov (NCT07416552). StuddyBuddy aggregates publicly available trial information.