Study of ²¹²Pb-DOTAM-GRPR1 for Advanced Cancers

This study is testing a new treatment called ²¹²Pb-DOTAM-GRPR1 for adults with advanced or metastatic (spread to other parts of the body) cancers that express GRPR. These cancers include certain types of cervical, breast, colon, non-small cell lung cancer (NSCLC), and metastatic castration-resistant prostate cancer (mCRPC). The main goal is to find the safest and most effective dose of ²¹²Pb-DOTAM-GRPR1. Researchers will also look at how the body handles the drug and if it helps shrink tumors. You may be able to join if you are an adult with one of these cancers. The study aims to determine the best dose within 14 months.

Study design
This is an open-label, Phase 1 study, meaning both you and the study team will know which treatment you are receiving. It involves a small number of participants (up to 48 planned) to test different doses.
What's involved
Participants will receive up to four cycles of the study drug, given every 4 or 6 weeks. There will also be a dosimetry sub-study for some participants to measure how the drug moves through the body.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for determining the recommended dose is measured at 14 months, suggesting follow-up will occur for at least this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05283330

Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Orano Med Theranostics, SAS
~48 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:²¹²Pb-DOTAM-GRPR1

At a glance

Recruiting sites
4 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine the Recommended Phase 2 Dose (RP2D) of ²¹²Pb-DOTAM-GRPR1
Measured over 14 months
Cervical Cancer
Breast Cancer
Colon Cancer
NSCLC
mCRPC (Metastatic Castration-resistant Prostate Cancer)
Glioblastoma
Nonsmall Cell Lung Cancer
8 sites across 6 states
Maryland2
Nebraska2
Illinois1
Iowa1
Kentucky1
Pennsylvania1

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  • To determine the Recommended Phase 2 Dose (RP2D) of ²¹²Pb-DOTAM-GRPR114 months

    Incidence of DLTs.