Actively Recruiting

Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
NCT05799274

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

Led by Radiopharm Theranostics, Ltd · Updated on 2026-05-05

9

Participants Needed

2

Research Sites

129 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Must be 18 years of age or older at the time of informed consent.
  • Willing and able to provide informed consent.
  • For cancer patients: confirmed diagnosis of pancreatic ductal adenocarcinoma, non-small cell lung cancer, esophageal squamous cell carcinoma, cervical cancer, endometrial cancer, or ovarian cancer.
  • Have had a standard of care CT or MRI within 12 weeks before consent showing at least one site of new or residual disease.
  • Screening lab values within 30 days before dosing: WBC ≥ 1200/µL, ANC ≥ 1000/µL, Platelets ≥ 75,000/µL, Hemoglobin ≥ 9.0 g/dL, Creatinine ≤ 1.5 mg/dL, AST/ALT ≤ 3 x ULN without liver metastases or ≤ 5 x ULN with liver metastases, Bilirubin ≤ 1.5 mg/dL (except Gilbert's disease).
  • Life expectancy of at least 12 weeks.
  • Baseline pulse oximetry ≥ 95% on room air.
  • Unremarkable ECG with PR interval < 200 msec and QTcF interval < 450 msec.
  • Willing to avoid illicit drugs from one week before PET scanning through follow-up on Day 3.
  • Willing to avoid donating blood for 4 weeks after RAD301 administration.
  • No participation in other drug studies within 4 weeks or 10 half-lives before imaging and safety follow-up period.
Not Eligible

You will not qualify if you...

  • Unable to understand the study or provide informed consent or have conditions interfering with study compliance.
  • Pregnant or breastfeeding women; women of childbearing potential must have a negative pregnancy test within 72 hours before dosing.
  • History of anaphylaxis to protein- or peptide-based therapies or diagnostic agents.
  • Conditions affecting drug absorption, distribution, metabolism, or elimination, including chronic liver or kidney failure.
  • Unable to tolerate study procedures.
  • Use of high-dose systemic corticosteroids (>10 mg/day prednisone equivalents) in the 2 weeks before dosing if having brain metastases.
  • Serious or uncontrolled medical disorders increasing study risks or interfering with results.
  • Significant cardiovascular or cerebrovascular disease within 6 months prior to enrollment.
  • Prior malignancy active within 3 years except certain cured local cancers.
  • Active autoimmune disease, except certain stable or non-recurring conditions.
  • Major surgery within 4 weeks before dosing, except diagnostic laparoscopy.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

United Theranostics

Princeton, New Jersey, United States, 08540

Actively Recruiting

2

Montefiore Medical Center

The Bronx, New York, United States, 10461

Actively Recruiting

Loading map...

Research Team

D

Dimitris Voliotis, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here