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

ConditionsCervical Cancer Breast Cancer Colon Cancer NSCLC mCRPC (Metastatic Castration-resistant Prostate Cancer)Glioblastoma Nonsmall Cell Lung Cancer

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorOrano Med Theranostics, SAS

About 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

Eligibility criteria

Qualifiers

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); HER2-negative including HER2-low (as per relevant ASCO/CAP guidelines)

Colorectal cancer

Cervical cancer

Disqualifiers

None

Trial design

Treatments tested in this trial

²¹²Pb-DOTAM-GRPR1

Treatment groups

48 Participants

are divided into 1 treatment group

Locations

Illinois

Northwestern University Robert H Lurie Medical Research60611, Chicago United States

Iowa

University of Iowa Health Care52242, Iowa City United States

Kentucky

UK Markey Cancer Center40536, Lexington United States

Maryland

Advanced Molecular Imaging and Therapy21061, Glen Burnie United States

Sponsors and collaborators

Orano Med Theranostics, SAS

Lead sponsor

Source ClinicalTrials.gov