²¹²Pb-DOTAM-GRPR1 for Cancer
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.12345Why 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.12456
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive single ascending doses (SAD) in a 3+3 design to determine the maximum tolerated dose
Multiple Ascending Dose (MAD)
Participants receive multiple ascending doses to determine the recommended phase 2 dose (RP2D)
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Orano Med LLC
Lead Sponsor
Citations
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 ...
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_ModelPreclinical 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.
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 ...
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 ...
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