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

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

Trial Details

NCT ID

NCT05283330

Phase

PHASE1

Sponsor

Orano Med LLC

Status

RECRUITING

Cancer Type

Colon Cancer Colorectal Cancer

Interventions

²¹²Pb-DOTAM-GRPR1

Locations (sample)

Chicago, Illinois, United States|41.85003,-87.65005
Lexington, Kentucky, United States|37.98869,-84.47772
Glen Burnie, Maryland, United States|39.16261,-76.62469
Omaha, Nebraska, United States|41.25626,-95.94043

Key Eligibility Criteria

Adult participants (age ≥ 18 years old) with any of the following advanced or metastatic solid tumors (documented history of histologically confirm…
Metastatic castration-resistant prostate cancer (mCRPC) including neuroendocrine prostate cancer (NEPC) (enrolled only in SAD and MAD Q6W)
HR+/HER2- breast cancer (estrogen receptor/ER expression \>10% of tumor cell nuclei stain, regardless of progesterone receptor/PgR expression); HER…
Colorectal cancer

For full eligibility, visit ClinicalTrials.gov.

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