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Radioisotope Therapy

²¹²Pb-DOTAM-GRPR1 for Cancer

Phase 1

Recruiting

Research Sponsored by Orano Med LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Sufficient bone marrow capacity and organ function as defined by: White blood cell (WBC) ≥2,500/ mm³, Absolute neutrophil count (ANC) ≥1500/mm³, Platelets ≥75,000/mm³, Hemoglobin (HgB) ≥9.0 g/dL

Biopsies must demonstrate 51-80% positively staining cells and moderate intensity of staining on immunohistochemistry (IHC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trialtests if a new drug is safe and effective for treating tumors that have a particular receptor.

Who is the study for?

Adults over 18 with certain advanced cancers (like prostate, breast, colon, lung cancer) that express GRPR and have failed at least two treatments. They must have measurable disease and be in fair health as shown by specific blood counts and organ function tests. Not for those with severe heart issues, recent heart attacks or unstable angina, history of pancreatitis or pneumonitis, known allergies to the study drug's components.Check my eligibility

What is being tested?

The trial is testing a new therapy called ²¹²Pb-DOTAM-GRPR1 on patients with GRPR-expressing tumors. It's a Phase 1 study which means they're starting to see how safe it is and what dose works best. Patients will receive increasing doses to find the maximum tolerated dose without serious side effects.See study design

What are the potential side effects?

Potential side effects are not fully known yet since this is an early-phase trial but may include typical reactions related to radiotherapy such as fatigue, skin reactions at the injection site, nausea or other gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood tests show enough white cells, neutrophils, platelets, and hemoglobin.

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My biopsy shows 51-80% of cells are positive with moderate intensity.

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I can take care of myself and am up and about more than half of the day.

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I am 18 or older with a confirmed cancer that has spread or come back and tests positive for GRPR.

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My condition worsened after two different treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To determine the Recommended Phase 2 Dose (RP2D) of ²¹²Pb-DOTAM-GRPR1

Secondary outcome measures

To assess half-live(s) (t½) of ²¹²Pb-DOTAM-GRPR1

To assess maximum concentration (Cmax) of ²¹²Pb-DOTAM-GRPR1

To assess the area under the curve (AUC) from time 0 to the time of the last quantifiable concentration of ²¹²Pb-DOTAM-GRPR1

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ²¹²Pb-DOTAM-GRPR1Experimental Treatment1 Intervention

In the dose escalation portion, a classic 3+3 design will be utilized. Doses will be increased by approximately 30% in subsequent cohorts. The maximum total dose that may be administered to a subject per cycle is 5.5 mCi +/- 10%. The maximum total dose that may be administered to a subject in the MAD regimen is 24 mCi over 4 cycles.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Orano Med LLCLead Sponsor

3 Previous Clinical Trials

119 Total Patients Enrolled

Jason D Hurt, MDStudy DirectorOrano Med

Media Library

²¹²Pb-DOTAM-GRPR1 (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05283330 — Phase 1

Breast Cancer Research Study Groups: ²¹²Pb-DOTAM-GRPR1

Breast Cancer Clinical Trial 2023: ²¹²Pb-DOTAM-GRPR1 Highlights & Side Effects. Trial Name: NCT05283330 — Phase 1

²¹²Pb-DOTAM-GRPR1 (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05283330 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different sites are administering this trial?

"At the moment, this medical trial is enrolling participants at 4 sites. These are found in Lexington, Glen Burnie and Omaha with one other site as well. It is best to choose a nearby location so you can cut down on travel arrangements if you decide to participate."

Answered by AI

Is participation in this research endeavor currently attainable for people?

"As per the latest update on clinicaltrials.gov, this trial is actively enrolling patients. It was initially opened to applicants on December 22nd 2022 and has been updated most recently on January 24th 2023."

Answered by AI

How many people are currently enrolled in this medical experiment?

"This trial requires 50 eligible participants to fulfill the requirements, and they can enrol from either UK Markey Cancer Center in Lexington or 331 Oak Manor Dr STE 201 in Glen Burnie."

Answered by AI

Has the U.S. Food and Drug Administration certified ²¹²Pb-DOTAM-GRPR1?

"Due to its Phase 1 trial status, with limited data supporting safety and efficacy, our team has provisionally assigned ²¹²Pb-DOTAM-GRPR1 a score of 1 on the safety scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05283330.

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