²¹²Pb-DOTAM-GRPR1 for Colon Cancer

Phase-Based Progress Estimates
Northwestern University Robert H Lurie Medical Research, Chicago, ILColon Cancer+5 More²¹²Pb-DOTAM-GRPR1 - Drug
All Sexes
What conditions do you have?

Study Summary

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

Eligible Conditions
  • Colon Cancer
  • Cervical Cancer
  • Hormone-Refractory Prostate Cancer
  • Breast Cancer
  • Non-Small Cell Lung Cancer
  • Skin Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 24 months

24 months
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
To assess the clearance (CL) of ²¹²Pb-DOTAM-GRPR1
To assess the safety and tolerability of ²¹²Pb-DOTAM-GRPR1 in subjects with gastrin-releasing peptide receptor (GRPR)-expressing tumors;
To assess the volume of distribution (Vd) of ²¹²Pb-DOTAM-GRPR1
To determine the Recommended Phase 2 Dose (RP2D) of ²¹²Pb-DOTAM-GRPR1
To evaluate the preliminary anti-tumor activity of the RP2D of ²¹²Pb-DOTAM-GRPR1

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: ²¹²Pb-DOTAM-GRPR1 · No Placebo Group · Phase 1

Experimental Group · 1 Intervention: ²¹²Pb-DOTAM-GRPR1 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Orano Med LLCLead Sponsor
3 Previous Clinical Trials
85 Total Patients Enrolled
Jason D Hurt, MDStudy DirectorOrano Med

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you have had the disease before, you must have tried and failed to improve with at least two different treatments.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.