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

Sponsors and collaborators

Orano Med Theranostics, SAS

Lead sponsor

Source ClinicalTrials.gov