RecruitingPhase 1NCT05799274

Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer or Other Solid Tumors

Characterizing the Radiochemical and Radiation Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Ductal Adenocarcinoma or Other Solid Tumors


Sponsor

Radiopharm Theranostics, Ltd

Enrollment

9 participants

Start Date

Nov 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1a, open label, single dose, extended study of safety and biokinetics of RAD301 in healthy human volunteers and individuals with PDAC or Other Solid Tumors


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety of a new drug called RAD301, first in healthy volunteers and then in patients with specific solid tumors — including pancreatic cancer, lung cancer, esophageal cancer, cervical cancer, endometrial cancer, and ovarian cancer. **You may be eligible if...** - You are 18 or older and able to give informed consent - For cancer patients: you have a confirmed diagnosis of one of these cancers (pancreatic, non-small cell lung, esophageal squamous, cervical, endometrial, or ovarian cancer) with at least one site of active or residual disease on recent imaging - For healthy volunteers: you must meet separate health screening criteria **You may NOT be eligible if...** - You have a cancer type not listed in the study - Your most recent scan is more than 12 weeks old and has not been confirmed by the study sponsor - Other health conditions or prior treatments disqualify you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRAD301 ([68Ga]-RAD301)

A single dose of 68Ga-RAD301 of 150 +/- 50 MBq (\~4mCi) administered as a slow bolus injection over 2-5 minutes


Locations(2)

United Theranostics

Princeton, New Jersey, United States

Montefiore Medical Center

The Bronx, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05799274


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