What this study is
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.
What's being tested
- SPLIT Abs
Intervention · DRUG
Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
- 203Pb-DOTAM
Intervention · DRUG
Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.
- 212Pb-DOTAM
Intervention · DRUG
Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.
Study details
- Official title
- A Phase I, Open-Label, Escalation and Expansion Study to Evaluate Dosimetry, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CEA-Pre-Targeted 212Pb Therapy in Participants With Metastatic Colorectal Cancer
- Sponsor
- Hoffmann-La Roche
- Conditions
- Metastatic Colorectal Cancer
- Enrolling
- 180 people
- Starts
- 2026-10-13
- Est. completion
- 2034-02-12
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (5)
5 openThe University of Chicago Medical Center
Chicago, Illinois, United States
RecruitingWashington University School of Medicine in St. Louis
St Louis, Missouri, United States
RecruitingNebraska Cancer Specialists
Omaha, Nebraska, United States
RecruitingMD Anderson Cancer Center
Houston, Texas, United States
RecruitingUniv of Wisconsin-Madison
Madison, Wisconsin, United States
Recruiting
Study team
Sponsor
Hoffmann-La Roche
Study ID BP45930
Study director
Clinical Trials
Hoffmann-La Roche
CONTACT
Reference Study ID Number: BP45930 https://forpatients.roche.com/ No attachments to email below.
CONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.