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Not yet recruiting NCT07416552

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

Phase I Interventional Metastatic Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SPLIT Abs, 203Pb-DOTAM, 212Pb-DOTAM.
Who it may be relevant to
Registry conditions: Metastatic Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug SPLIT Abs
    Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
  • Drug 203Pb-DOTAM
    Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.
  • Drug 212Pb-DOTAM
    Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.

Primary outcome measures

  • Part 1: Serum Concentration of SPLIT Abs [Time frame: Up to approximately 48 weeks]
  • Part 1: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM [Time frame: Up to approximately 48 weeks]
  • Part 1 to 2: Absorbed Radiation Dose of 212Pb-DOTAM extrapolated from 203Pb-DOTAM [Time frame: Up to approximately 48 weeks]
  • Part 1 to 3: Percentage of Participants With Adverse Events (AE) [Time frame: Up to approximately 5 years]
Secondary outcome measures (11)
  • Part 1 to 2: Uptake of 203Pb-DOTAM in Tumor and Normal Tissue [Time frame: Up to approximately 48 weeks]
  • Part 1 to 2: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM [Time frame: Up to approximately 48 weeks]
  • Part 1 to 3: Serum Concentration of CEA-PRIT 2.0 [Time frame: Up to approximately 48 weeks]
  • Part 1 to 3: Time Course of Blood and Plasma Radioactivity for 212Pb-DOTAM [Time frame: Up to approximately 48 weeks]
  • Part 1 to 3: Percentage of Participants With Anti-Drug Antibodies (ADAs) Against SPLIT Abs [Time frame: Baseline, Up to approximately 48 weeks]
  • Part 1 to 3: Objective Response Rate (ORR) [Time frame: Up to approximately 48 weeks]
  • Part 1 to 3: Disease Control Rate (DCR) [Time frame: Up to approximately 48 weeks]
  • Part 1 to 3: Duration of Response (DOR) [Time frame: Up to approximately 48 weeks]
  • Part 1 to 3: Progression-Free Survival (PFS) [Time frame: Up to approximately 48 weeks]
  • Part 1 to 3: Overall Survival (OS) [Time frame: Up to approximately 48 weeks]
  • Part 1 to 3: Correlation Between Carcinoembryogenic Antigen (CEA) Tumor Expression and Clinical Activity [Time frame: Up to approximately 48 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Nebraska Cancer Specialists — Omaha

Identifiers

NCT: NCT07416552 · BP45930 · 2025-523322-40-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗