²¹²Pb-DOTAM-GRPR1 for Cancer

Recruiting at 5 trial locations

Overseen By Orano Med LLC

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Orano Med LLC

Must not be taking: GRPR-targeting agents

Disqualifiers: Whole-body radiotherapy, Chronic pancreatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

30 Participants Needed

Trial Summary

What is the purpose of this trial?

A Phase 1 SAD/MAD dose escalation and expansion study to determine the safety and effectiveness of ²¹²Pb-DOTAM-GRPR1 in subjects with various GRPR-expressing Tumors

Research Team

Jason D Hurt, MD

Principal Investigator

Orano Med

Eligibility Criteria

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.

Inclusion Criteria

I have at least one tumor that can be measured by scans taken within the last month.

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

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

Exclusion Criteria

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

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive single ascending doses (SAD) in a 3+3 design to determine the maximum tolerated dose

Varies per cohort

Multiple visits for dose administration and monitoring

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses to determine the recommended phase 2 dose (RP2D)

Up to 4 cycles, each 8 weeks apart

Visits every 8 weeks for dose administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• ²¹²Pb-DOTAM-GRPR1

Trial Overview 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.

Participant Groups

Group I: ²¹²Pb-DOTAM-GRPR1 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Orano Med LLC

Lead Sponsor

Trials

4

Recruited

150+