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RECRUITING Phase 1

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

NCT05283330 · View on ClinicalTrials.gov ↗

Study 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

Interventions

  • DRUG ²¹²Pb-DOTAM-GRPR1

Study Locations (4)

Illinois

  • Northwestern University Robert H Lurie Medical Research — Chicago

Kentucky

  • UK Markey Cancer Center — Lexington

Maryland

  • Advanced Molecular Imaging and Therapy — Glen Burnie

Nebraska

  • XCancer Omaha / Urology Cancer Center — Omaha

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2022-12-22
Est. Completion 2032-05
Phase Phase 1

Sponsor

Orano Med

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05283330

The ClinicalTrials.gov registry entry for NCT05283330 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orano Med, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention — of which ²¹²Pb-DOTAM-GRPR1 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05283330 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Illinois, Kentucky, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05283330 about?

NCT05283330 is a clinical study titled "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

What is the current status of trial NCT05283330?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2022-12-22. Estimated completion is 2032-05.

What conditions does trial NCT05283330 study?

This clinical trial studies the following conditions: Breast Cancer, Glioblastoma, Cervical Cancer, Colon Cancer, NSCLC. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05283330?

The interventions under investigation include: ²¹²Pb-DOTAM-GRPR1 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05283330?

This trial is sponsored by Orano Med, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05283330 being conducted?

This trial has 4 study locations across Illinois, Kentucky, Maryland, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial