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

NCT07416552
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
180
clinicaltrials.gov
Lead sponsor
Hoffmann-La Roche
clinicaltrials.gov
Start date
2026-09-08
clinicaltrials.gov
Number of sites
2
clinicaltrials.gov

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.
clinicaltrials.gov
Short title
A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)
clinicaltrials.gov
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
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2034-02-12
clinicaltrials.gov
First posted
2026-02-18
clinicaltrials.gov
Registry last updated
2026-08-10
clinicaltrials.gov
Primary completion date
2034-02-12
clinicaltrials.gov
Start date
2026-09-08
clinicaltrials.gov

Participants
180
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
180
clinicaltrials.gov
Protocol amendments
0
clinicaltrials.gov
Number of sites
2
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Hoffmann-La Roche
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07416552
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07416552
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Part 1: Serum Concentration of SPLIT Abs

    Timeframe: Up to approximately 48 weeks

  2. Part 1: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM

    Timeframe: Up to approximately 48 weeks

  3. Part 1 to 2: Absorbed Radiation Dose of 212Pb-DOTAM extrapolated from 203Pb-DOTAM

    Timeframe: Up to approximately 48 weeks

  4. Part 1 to 3: Percentage of Participants With Adverse Events (AE)

    Timeframe: Up to approximately 5 years

  1. Part 1 to 2: Uptake of 203Pb-DOTAM in Tumor and Normal Tissue

    Timeframe: Up to approximately 48 weeks

  2. Part 1 to 2: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM

    Timeframe: Up to approximately 48 weeks

  3. Part 1 to 3: Serum Concentration of CEA-PRIT 2.0

    Timeframe: Up to approximately 48 weeks

  4. Part 1 to 3: Time Course of Blood and Plasma Radioactivity for 212Pb-DOTAM

    Timeframe: Up to approximately 48 weeks

  5. Part 1 to 3: Percentage of Participants With Anti-Drug Antibodies (ADAs) Against SPLIT Abs

    Timeframe: Baseline, Up to approximately 48 weeks

  6. Part 1 to 3: Objective Response Rate (ORR)

    Timeframe: Up to approximately 48 weeks

  7. Part 1 to 3: Disease Control Rate (DCR)

    Timeframe: Up to approximately 48 weeks

  8. Part 1 to 3: Duration of Response (DOR)

    Timeframe: Up to approximately 48 weeks

  9. Part 1 to 3: Progression-Free Survival (PFS)

    Timeframe: Up to approximately 48 weeks

  10. Part 1 to 3: Overall Survival (OS)

    Timeframe: Up to approximately 48 weeks

  11. Part 1 to 3: Correlation Between Carcinoembryogenic Antigen (CEA) Tumor Expression and Clinical Activity

    Timeframe: Up to approximately 48 weeks

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Nebraska Cancer SpecialistsOmaha, United StatesRecruiting
  • Univ of Wisconsin-MadisonMadison, United StatesRecruiting
Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-523322-40-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)