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

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ²¹²Pb-DOTAM-GRPR1, designed for individuals with certain recurrent or metastatic tumors that express GRPR. The main goal is to assess the treatment's safety and effectiveness. People with cancers such as prostate, breast, colorectal, cervical, melanoma, or non-small-cell lung cancer who have not responded to at least two treatments may be suitable candidates. Participants will assist researchers in determining the correct dosage and understanding the body's response to this new treatment. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had any systemic anticancer therapy within 4 weeks before starting the study, except for certain hormone therapies for prostate cancer. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that ²¹²Pb-DOTAM-GRPR1 is likely to be safe for humans?

Research has shown that ²¹²Pb-DOTAM-GRPR1 has promising safety results from early tests. These tests, conducted in labs and on animals, found that the treatment was generally well-tolerated, meaning it didn't cause serious side effects. However, this treatment is still in the early stages of human testing.

As a Phase 1 trial, this is the first time ²¹²Pb-DOTAM-GRPR1 is being tested in humans. The main goal is to assess its safety and identify any potential side effects. While early lab results are encouraging, its safety for humans remains under investigation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

²¹²Pb-DOTAM-GRPR1 is unique because it uses a novel radioactive isotope, lead-212 (²¹²Pb), to target cancer cells. Unlike traditional treatments like chemotherapy and external radiation, which can affect both healthy and cancerous cells, this treatment targets the gastrin-releasing peptide receptor (GRPR) found on certain cancer cells, providing a more precise attack. Researchers are excited because this targeted approach could potentially reduce side effects and improve effectiveness compared to existing therapies. Additionally, the treatment's ability to deliver radiation directly to the cancer cells offers a promising new mechanism of action in the fight against cancer.

What evidence suggests that ²¹²Pb-DOTAM-GRPR1 might be an effective treatment for GRPR-expressing tumors?

Research shows that ²¹²Pb-DOTAM-GRPR1, the treatment under study in this trial, could be a promising cancer therapy. In animal studies, tumors treated with this compound led to longer survival times. Specifically, animals receiving ²¹²Pb-DOTAM-GRPR1 lived about 19 weeks, compared to just 9 weeks for those without the treatment. This treatment delivers targeted radiation directly to cancer cells, offering precision and effectiveness. Although these results come from early animal studies, they provide hope for its potential effectiveness in humans with certain types of tumors. ^{1 2 4 5 6}

Who Is on the Research Team?

Jason D Hurt, MD

Principal Investigator

Orano Med

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

In the dose escalation portion, a classic 3+3 design will be utilized for the SAD cohorts and a TITE Boin design for the MAD cohorts. Doses will be increased by approximately 30% in subsequent cohorts. The maximum total dose that may be administered to a subject per cycle is 6.0 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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39327021/

Preclinical Investigation of [212Pb]Pb-DOTAM-GRPR1 for ... Efficacy studies indicated a median survival time of 9 wk in the control group, which received only a buffer solution, compared with 19 wk in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05283330

NCT05283330 | Safety and Tolerability of ²¹²Pb-DOTAM- ... To assess the safety and tolerability of ²¹²Pb-DOTAM-GRPR1 in subjects with gastrin-releasing peptide receptor (GRPR)-expressing tumors; Measured as the number ...

3. researchgate.net researchgate.net/publication/384390461_Preclinical_Investigation_of_212_PbPb-DOTAM-GRPR1_for_Peptide_Receptor_Radionuclide_Therapy_in_a_Prostate_Tumor_Model

Preclinical Investigation of [ 212 Pb]Pb-DOTAM-GRPR1 for ... Efficacy studies indicated a median survival time of 9 wk in the control group, which received only a buffer solution, compared with 19 wk in ...

4. openmedscience.com openmedscience.com/lead-212-dotam-grpr1-a-novel-radioimmunoconjugate-for-targeted-cancer-therapy/

Lead-212 DOTAM-GRPR1 Cancer Treatment Lead-212 DOTAM-GRPR1 targets GRPR-expressing tumours, delivering potent alpha radiation for precise and effective cancer therapy.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11533912/

Preclinical Investigation of [212Pb]Pb-DOTAM-GRPR1 for ... In preclinical studies, the efficacy of 212Pb as an antitumor agent has been demonstrated in various animal cancer models, including peritoneal ...

6. withpower.com withpower.com/trial/phase-1-malignant-neoplasm-of-colon-4-2022-888cb

²¹²Pb-DOTAM-GRPR1 for Cancer · Recruiting Participants ... This Phase 1 medical study run by Orano Med LLC is evaluating whether ²¹²Pb-DOTAM-GRPR1 will have tolerable side effects & efficacy for patients with Colon ...