Study Title

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

Study Details

Description:

The objective of this clinical trial is to determine the safety of an intravenously administered radiotracer, RAD301 ([68Ga]-Trivehexin), in either healthy volunteers or patients with pancreatic cancer. All participants will undergo: Screening, which entails physical examination and blood samples for standard blood testing. Participants that successfully pass screening will undergo: Gallium-68 PET scanning procedures, which will occur during a single day (about 5-6 hours). These participants will return to the clinic at 2 weeks for additional safety labs. All scanned participants will also be evaluated by telephone follow up on a weekly basis for 1 month after scanning.

Sponsor:

Radiopharm Theranostics

Contacts:

Lionel S Zuckier, MD

lzuckier@montefiore.org

(+1) 718 405 8454

Government Study Link:

NCT05799274 - Click here to see study on

ClinicalTrials.gov

Drug Details

Isotope(s):

GALLIUM-68

Radioisotope: Ga-68

Theranostic Role: PET Imaging

T1/2 (Half-Life): 68 minutes

Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)

Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV

Range: N/A

Decay Daughters: Zn68 (Stable)

Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)

GALLIUM-68

Target(s):

αvβ6

Ligand: Peptides

Inclusion

Patients may participate regardless of where they are in the course of their illness
Healthy volunteers should be subjectively healthy and likely to tolerate the imaging procedures
Patients should have a life expectancy of ≥ 12 weeks
Patients with a history of histologically or cytologically confirmed PDAC & a recent SoC CT or MRI prior to consent
Screening laboratory values within 30 days prior to administration of the study drug

Exclusion

May not have taken any experimental study drugs in the 4 weeks prior to PET scanning
May not have been exposed to radiation during research producing an Effective Dose of >10 mSv during the last 12 months
A prior malignancy active within the previous 3 years except for locally curable cancers that have been cured
Patients who underwent major surgery within 4 weeks of enrollment
Patients with brain metastases are eligible as long as there is no requirement for high doses of corticosteroids

Patient Education

Patient Education Not Yet Provided

Publications

This paper reports the successful application of 68Ga-Trivehexin for imaging of human carcinomas with elevated avB6 integrin expression, including PDAC.

Locations

United States

Montefiore Medical Center

Bronx, New York 10461, United States

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Principal Investigator: