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

Study acronym: RAD301
StatusActive, Not Recruiting
PhasePhase 1
Started2023-11-09
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later May 2026 → Aug 2026
See other at-risk trials from Radiopharm Theranostics, Ltd

Amendment history

2026-09-09
Study Status, Contacts/Locations v11
Enrollment closed, study ongoing
Primary completion date2026-08→2026-09
Completion date2026-08→2026-09
Study sitesdetails revised at 2 of 2 sites
2026-07-15
Study Status, Contacts/Locations v10
Primary completion pushed: 2026-05 → 2026-08
Completion pushed: 2026-05 → 2026-08
Study sitesdetails revised at 2 of 2 sites
2026-04-29
Study Status v9
Primary completion pushed: 2026-03 → 2026-05
Completion pushed: 2026-03 → 2026-05
2026-03-24
Study Status v8
Primary completion date2025-11→2026-03
Completion date2025-11→2026-03
2025-11-18
Study Identification, Study Status, Oversight, Study Description, Conditions, Eligibility v7
Eligibility criteria+483 characters
Inclusion Criteria: Must be ≥ 18 years of age at the time of signing the informed consent. All participants must be willing and able to give written informed consent. For patients with PDACcancer: have a history of histologically or cytologically confirmed PDAC, non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma, cervical cancer, endometrial cancer, or ovarian cancer and have had a SOC CT or MRI within 812 weeks prior to signinggiving consent that indicates the presence of at least 1 site of new or residual disease. If the SOC CT or MRI has occurred prior to 12 weeks, consu [...] [...]
Study description+62 characters
[...] RAD301 in healthy human volunteers and individuals with PDAC or Other Solid Tumors. The procedures will be similar in both groups, but there c [...] ns in healthy volunteers and fewer in individuals with PDAC or Other Solid Tumors during the same time interval if individuals are intolerant [...] 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 fi [...] scans could be repeated. This second imaging session (WB PET only-CT) will be optional and depends on the robustness of the indi [...] urs. There will be a third, or final imaging s [...]
Study title+22 characters
Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer or Other Solid Tumors
Show 6 earlier versions
2025-09-23
Study Status v6
Primary completion date2025-08→2025-11
Completion date2025-08→2025-11
2025-07-15
Study Status, Contacts/Locations v5
Primary completion date2025-05→2025-08
Completion date2025-05→2025-08
Study sites1→2
2025-04-29
Study Identification, Study Status v4
Primary completion date2025-03→2025-05
Completion date2025-03→2025-05
Study titlerevised
Safety of RAD301 in Healthy Human Volunteers and Patients withWith Pancreatic Cancer
2025-03-16
Study Status, Contacts/Locations v3
Study sitescontacts updated at 1 of 1 site
2025-03-05
Study Identification, Study Status, Oversight, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Primary completion date2024-06→2025-03
Completion date2024-09→2025-03
Study arms0→1
InterventionsRAD301 ([68Ga]-Trivehexin) (Drug)→RAD301 ([68Ga]-RAD301) (Drug)
Eligibility criteria-1,380 characters
Inclusion Criteria: Must be ≥ 18 years of age at the time of signing the informed consent. All subjectsparticipants must be willing and able to give written informed consent. HealthyFor volunteers should be subjectively healthy and, in the opinion of the investigators, likely to tolerate the imaging procedures and be compliant with the schedule of follow up telephone calls. Patientspatients with PDAC should be well enough to tolerate the imaging procedures. They should: have a history of histologically or cytologically confirmed pancreaticPDAC ductaland adenocarcinomahave (PDAC). Patientshad m [...] [...]
Primary endpoints3 entries, revised
ChangesRadiation indosimetry VSsof RAD301 Radiation dosimetry of RAD301 Safety and ECGs, such as the PR and QTcF intervals; as percentages and absolute values approaching critical safety zones Numbertolerability of participants with abnormal laboratory test results Radiation Absorbed Doses in internal organs, in units of mGy and mSvRAD301
Study description-3,243 characters
Intervention Description: Single administrations of a radiopharmaceutical at a dose below the no observable (pharmacological) effect level (NOEL). Primary Objective: To characterize the radiation and radiochemical safety profile of RAD301 in healthy adults and patients with PDAC. Primary Endpoints: [...] This will be a Phase 1a, open label, single dose, extended study of safety and biokinetics of RAD301 in three healthy human volunteers (HV) and six patientsindividuals with pancreatic ductal adenocarcinoma (PDAC). The procedures will be nearly identicalsimilar in both groups, but there could be more [...] [...]
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Safety of RAD301 in Healthy Human Volunteers and Patients Withwith Pancreatic Cancer
2023-11-15
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-08→2024-06
Completion date2023-09→2024-09
Start dateestimated 2023-05→confirmed 2023-11-09
Study sites0→1
2023-03-22
Original filing
Radiopharm Theranostics, Ltd
7 trials monitored
See 3 trials at risk
Lung Cancer
4,033 trials monitored
See 210 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,914 trials monitored
See 156 trials at risk
Pancreatic Cancer
1,634 trials monitored
See 90 trials at risk
and 4 more diseases
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
Trial Details
NCT Number NCT05799274
Lead Sponsor Radiopharm Theranostics, Ltd
Conditions Healthy Volunteers, Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer (NSCLC), Esophageal Squamous Cell Carcinoma, Cervical Cancer, Endometrial Cancer, Ovarian Cancer
Enrollment 9 participants
Start Date 2023-11-09
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-14