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Clinical Trials in the USA / NCT07416552
Recruiting Phase 1

A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)

NCT07416552 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 1
Started
2026-09-08
Last updated
2026-09-04

Condition(s) studied

Metastatic Colorectal Cancer

Investigational drug(s) / intervention(s)

SPLIT Abs203Pb-DOTAM212Pb-DOTAM

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)

Trial sites (3)

FacilityCityRegionStatus
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.

View NCT07416552 on ClinicalTrials.gov ↗ ← All trials in the USA