SPLIT Abs: Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
203Pb-DOTAM: Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.
212Pb-DOTAM: Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Part 1: Serum Concentration of SPLIT Abs — Up to approximately 48 weeks
Part 1: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM — Up to approximately 48 weeks
Part 1 to 2: Absorbed Radiation Dose of 212Pb-DOTAM extrapolated from 203Pb-DOTAM — Up to approximately 48 weeks
Part 1 to 3: Percentage of Participants With Adverse Events (AE) — Up to approximately 5 years
Trial sites (3)
Facility
City
Region
Status
Nebraska Cancer Specialists
Omaha
Nebraska
Recruiting
MD Anderson Cancer Center
Houston
Texas
Recruiting
Univ of Wisconsin-Madison
Madison
Wisconsin
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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