A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)
Recruiting · NCT07416552 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
203Pb-DOTAM212Pb-DOTAMSPLIT Abs
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 \<4 weeks prior to the first CEA-PRIT 2.0 administration (excluding biopsies) or anticipation of the need for major surgery during study treatment
- Participants have a known confirmed positive test for HIV
- Positive hepatitis B surface antigen (HBsAg) test, and/or positive total hepatitis B core Ab (HBcAb) test at screening.
- Positive hepatitis C (HCV) Ab test result at screening
- Any anticancer treatment or any investigational agent within 4 weeks (or 5 times the half-life, whichever is shorter) prior to C1D1
- Prior treatment with a CEA-targeted agent or systemic radio therapy
Where it is running
2 locations listed across 2 US states.
- Nebraska Cancer Specialists - Omaha, Nebraska, United States
- Univ of Wisconsin-Madison - Madison, Wisconsin, United States