Characterizing the Radiochemical and Radiation Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Ductal Adenocarcinoma or Other Solid Tumors
Radiopharm Theranostics, Ltd
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
Description
This will be 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. The procedures will be similar in both groups, but there could be more scans in healthy volunteers and fewer in individuals with PDAC or Other Solid Tumors during the same time interval if individuals are intolerant of lying still on an imaging table for long periods of time. All individuals will have vital signs, ECGs, and blood for safety assessments collected before and 2 weeks after a single dose, intravenous (IV)…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Must be ≥ 18 years of age at the time of informed consent. 2. All participants must be willing and able to give informed consent. 3. For patients with cancer: have a history of histologically or cytologically confirmed PDAC, non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma, cervical cancer, endometrial cancer, or ovarian cancer and have had a SOC CT or MRI within 12 weeks prior to giving consent that indicates the presence of at least 1 site of new or residual disease. If the SOC CT or MRI has occurred prior to 12 weeks, consultation with the Spons…
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 TheranosticsPrinceton, New Jersey
- Montefiore Medical CenterThe Bronx, New York