Safety Study of RAD301 for Cancer and Healthy Volunteers

This study is looking at the safety of a drug called RAD301 ([68Ga]-RAD301) in healthy volunteers and people with certain cancers, including pancreatic, non-small cell lung, esophageal, cervical, endometrial, or ovarian cancer. The researchers want to see how the body handles RAD301 and how much radiation it gives off. You would receive a single dose of RAD301 through an IV (intravenous) and have scans to track it. The study will also check for any side effects over four weeks. This is an early-stage study, and the enrollment status is currently unclear.

Study design
This is an early-stage, open-label study involving a single dose of RAD301. It plans to enroll 9 participants, including healthy volunteers and those with specific solid tumors.
What's involved
You would receive a single IV dose of RAD301. You would have vital signs, ECGs (heart tests), and blood tests before and two weeks after the dose, plus three whole-body PET-CT and PET scans.
Compensation
Not stated in the trial record.
Follow-up
Your safety and tolerability of RAD301 will be measured for four weeks after the dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05799274

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

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Radiopharm Theranostics, Ltd
~9 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:RAD301 ([68Ga]-RAD301)

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiation dosimetry of RAD301
Measured over 6 hours
+2 more outcomes measured
Healthy Volunteers
Pancreatic Ductal Adenocarcinoma
Non-small Cell Lung Cancer (NSCLC)
Esophageal Squamous Cell Carcinoma
Cervical Cancer
Endometrial Cancer
Ovarian Cancer
2 sites across 2 states
New Jersey1
New York1

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  • Radiation dosimetry of RAD3016 hours

    Absorbed radiation dose of RAD301 in critical organs

  • Radiation dosimetry of RAD3016 hours

    Absorbed radiation dose of RAD301 in tumor lesions

  • Safety and tolerability of RAD3014 weeks

    The properties, incidence, nature and severity of AEs and SAEs per Common Terminology Criteria for Adverse Events (CTCAE) v5.0