Trials / Recruiting

RecruitingNCT05799274

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

Status: Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 9 (estimated)

Sponsor: Radiopharm Theranostics, Ltd · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Accepted

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

Detailed 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) administration of the investigational radiopharmaceutical, RAD301, at a dose of 150 ± 50 MBq (\~ 4 mCi). There will be 3 whole body (WB) PET-CT and PET scanning sessions. The initial WB acquisition should take approximately 10 minutes. A subsequent WB PET-only scan will be performed approximately 45 minutes after the injection. As time passes and less radioactivity is localizable to the distal extremities, the scan length may be decreased from vertex-to-thighs. The duration of each scan may increase to partially compensate for radioactive decay. More than one WB scan may be performed in healthy volunteers during the first imaging session, but only one scan will be required in individuals with PDAC or Other Solid Tumors who are not able to tolerate additional scans. The entire first imaging session will last up to approximately 2 hours. The individuals will then be given a rest period (lunch break) after which the sequence of imaging scans could be repeated. This second imaging session (WB PET-CT) will be optional and depends on the robustness of the individual and the availability of the clinical scanner. The second imaging session will take place mid-day, after the break, and will last up to 1.5 hours. There will be a third, or final imaging session (WB PET-CT) at the end of the day for all participants, which will strive to include the time interval after approximately 4 physical half-lives of Gallium-68 (Ga-68). The third imaging session will last up to 1.5 hours.

Conditions

Interventions

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

Timeline

Start date: 2023-11-09
Primary completion: 2026-03-01
Completion: 2026-03-01
First posted: 2023-04-05
Last updated: 2026-03-30

Locations

2 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05799274. Inclusion in this directory is not an endorsement.