²¹²Pb-DOTAM-GRPR1 for Cancer
Trial Summary
What is the purpose of this trial?
A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or Metastatic GRPR-expressing Tumors
Research Team
Jason D Hurt, MD
Principal Investigator
Orano Med
Eligibility Criteria
Adults over 18 with certain advanced cancers (like prostate, breast, colon, lung cancer) that express GRPR and have failed at least two treatments. They must have measurable disease and be in fair health as shown by specific blood counts and organ function tests. Not for those with severe heart issues, recent heart attacks or unstable angina, history of pancreatitis or pneumonitis, known allergies to the study drug's components.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive single ascending doses (SAD) in a 3+3 design to determine the maximum tolerated dose
Multiple Ascending Dose (MAD)
Participants receive multiple ascending doses to determine the recommended phase 2 dose (RP2D)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ²¹²Pb-DOTAM-GRPR1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Orano Med LLC
Lead Sponsor