Health TrialsbyHealthPanel

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

ConditionMetastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • SPLIT Abs

    Drug

    Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.

  • 203Pb-DOTAM

    Drug

    Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.

  • 212Pb-DOTAM

    Drug

    Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Part 1 (Dosimetry)Experimental treatment 3 interventions
Group B: Part 2 (212Pb-DOTAM Administered Activity Escalation)Experimental treatment 3 interventions
Group C: Part 3 (Expansion)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part 1: Serum Concentration of SPLIT Abs

Time frame
Up to approximately 48 weeks
2

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

Time frame
Up to approximately 48 weeks
3

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

Time frame
Up to approximately 48 weeks
4

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

Time frame
Up to approximately 5 years

Secondary outcomes

1

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

Time frame
Up to approximately 48 weeks
2

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

Time frame
Up to approximately 48 weeks
3

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

Time frame
Up to approximately 48 weeks
4

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

Time frame
Up to approximately 48 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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