RecruitingPhase 1NCT05283330

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


Sponsor

Orano Med LLC

Enrollment

48 participants

Start Date

Dec 22, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new radioactive drug called ²¹²Pb-DOTAM-GRPR1, which targets a protein (GRPR) found on certain tumors. It is being studied in adults with advanced cancers including prostate cancer, breast cancer, colorectal cancer, cervical cancer, lung cancer, and recurrent glioblastoma (brain tumor). The drug delivers targeted radiation directly to cancer cells. **You may be eligible if...** - You are 18 or older with one of the listed cancer types that has progressed after at least 2 prior treatments - A special scan (SPECT/CT) confirms your tumor has the GRPR target protein - Your blood counts, kidney, and liver function are adequate - For glioblastoma specifically: your tumor has come back after initial standard treatment **You may NOT be eligible if...** - Your ECOG performance status is worse than 1 (meaning your daily function is significantly limited) - Your kidney function is below the required threshold - Your tumor does not show GRPR uptake on scanning Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG²¹²Pb-DOTAM-GRPR1

²¹²Pb-DOTAM-GRPR1 is a radioimmunoconjugate comprised of ²¹²Pb, the metal chelator DOTAM (1,4,7,10-Tetrakis(carbamoylmethyl)-1,4,7,10- tetraazacyclododecane) and a GRPR-targeted antagonist.


Locations(4)

Northwestern University Robert H Lurie Medical Research

Chicago, Illinois, United States

UK Markey Cancer Center

Lexington, Kentucky, United States

Advanced Molecular Imaging and Therapy

Glen Burnie, Maryland, United States

XCancer Omaha / Urology Cancer Center

Omaha, Nebraska, United States

View Full Details on ClinicalTrials.gov

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NCT05283330


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