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

Part of paid clinical trials in Princeton, New Jersey.

Sponsor
Radiopharm Theranostics, Ltd
Study ID
NCT05799274
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Nov 9, 2023
Status verified
Nov 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: [68Ga]-RAD301
    150 +/- 50 MBq (\~4 mCi) single dose administered at Day 1 visit

Primary Outcome Measure

Radiation dosimetry of RAD301 [ Time Frame: 6 hours ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
United TheranosticsPrincetonNew Jersey08540
Patient Recruitment
[email protected]
667-HOPENOW
Montefiore Medical CenterThe BronxNew York10461
Gunjan Garg, MD
[email protected]
718-405-8454

Find similar trials in Princeton, NJ

By condition
Cervical cancerEndometrial cancerOvarian cancerPancreatic cancer
By specialty
OncologyGynecologic oncologyWomen's healthGI oncology
By research site
United Theranostics· Princeton, NJMontefiore Medical Center· The Bronx, NY

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