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

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

Age range

18+ years

Sex

All

Healthy volunteers

No

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.

Locations (3)