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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)

Must not have

Previous whole-body radiotherapy or peptide receptor radionuclide therapy (PRRT) with either alpha or beta emitters, or subjects with mCRPC who have received radium-223 (²²³Ra)

Cyclical chemotherapy, radiotherapy, or biologic therapy (e.g. antibodies), continuous or intermittent, small molecule therapeutics, or any investigational agents within a period which is ≤ 5 half-lives or ≤ 4 weeks (whichever is longer) prior to Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had whole-body radiation or specific cancer-targeting radiation treatments.

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I haven't had certain cancer treatments in the last 4 weeks or within 5 half-lives of the treatment, whichever is longer.

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My heart function is impaired, as indicated by recent heart issues or specific test results.

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I have a long-term inflammation of my pancreas.

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I have not been treated with drugs targeting GRPR.

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I have had pneumonitis before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 11Eligibility criteria met