RAD301 Safety for Pancreatic Cancer

(RAD301 Trial)

Recruiting at 2 trial locations

Overseen By Dimitris Voliotis, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Radiopharm Theranostics, Ltd

Must not be taking: Systemic corticosteroids

Disqualifiers: Pregnancy, Atopia, Cardiovascular disease, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

9 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of a new treatment called RAD301 for individuals with pancreatic cancer. Researchers aim to assess how the body processes this treatment and its effects. The trial involves a single dose to evaluate its safety in both healthy individuals and those with pancreatic cancer. Suitable candidates include those with doctor-confirmed pancreatic cancer and recent scans showing the disease. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the RAD301 trial?

The trial information does not specify if you need to stop taking your current medications. However, you must refrain from taking illicit drugs one week before and four weeks after the study drug, and you cannot participate if you've been in another study requiring medication recently.

Is there any evidence suggesting that RAD301 is likely to be safe for humans?

Research shows that RAD301 is being tested for safety in both healthy individuals and those with pancreatic cancer. As this study is in an early stage, it focuses on the safety of RAD301 and its behavior in the body. Testing in healthy volunteers first ensures the treatment's safety before proceeding to further tests.

While detailed safety information is not yet available, early trials like this one aim to identify any side effects or risks. Known side effects at this stage should be mild and manageable. Testing in healthy volunteers indicates confidence in its safety so far. However, more testing is necessary to fully understand its safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for pancreatic cancer, which typically include chemotherapy, radiation, or surgery, RAD301 is a novel approach that uses a radioactive tracer, [68Ga]-RAD301, to potentially improve diagnosis and monitoring. This treatment is unique because it involves a new delivery method—a single dose of a radioactive compound. Researchers are excited about RAD301 because it could offer a more precise way to detect and track cancerous cells, possibly leading to better-targeted treatments and improved patient outcomes.

What evidence suggests that RAD301 might be an effective treatment for pancreatic cancer?

Research has shown that RAD301, also known as 68Ga-Trivehexin, could aid in detecting pancreatic cancer. It targets a protein called αvβ6-integrin, commonly found in this cancer type. By focusing on this protein, RAD301 can help doctors visualize the cancer more clearly, potentially assisting in treatment planning. Early studies suggest that RAD301 is safe for patients, but further research is needed to fully assess its effectiveness in detecting pancreatic cancer. Participants in this trial will receive a single dose of [68Ga]-RAD301 to further evaluate its safety and effectiveness. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for healthy volunteers and patients with pancreatic cancer (PDAC) who can consent to the study. Healthy participants should be able to handle imaging procedures and follow-up calls. Cancer patients must tolerate these procedures, have confirmed PDAC, and likely survive the follow-up period.

Inclusion Criteria

I can avoid recreational drugs and limit alcohol to less than one drink a day before my PET scan.

I agree not to join other drug studies 4 weeks before and after taking RAD301.

I agree not to get vaccinated 4 weeks before and after taking RAD301.

Exclusion Criteria

I am not on high doses of steroids for brain metastases.

I do not have any serious health issues that could make this study unsafe for me.

Unremarkable electrocardiograms with specific PR and QTcF intervals.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Single dose administration of RAD301 and multiple imaging sessions to assess safety and biokinetics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RAD301

Trial Overview The safety of RAD301 ([68Ga]-Trivehexin), a radioisotope given through IV, is being tested in this trial. Participants will undergo Gallium-68 PET scans and return for safety lab tests after two weeks, with weekly phone check-ups for one month.

How Is the Trial Designed?

Group I: [68Ga]-RAD301 Experimental Treatment 1 Intervention

150 +/- 50 MBq (\~4 mCi) single dose administered at Day 1 visit

Who Is Running the Clinical Trial?

Radiopharm Theranostics, Ltd

Lead Sponsor

Trials

4

Recruited

100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05799274

Safety of RAD301 in Healthy Human Volunteers and ... This will be a Phase 1a, open label, single dose, extended study of safety and biokinetics of RAD301 in healthy human volunteers and individuals with PDAC.

2. radiopharmtheranostics.com radiopharmtheranostics.com/rad-301-shows-strong-imaging-potential-in-pancreatic-cancer/

RAD 301 shows strong imaging potential in pancreatic ... 68Ga-RAD 301 (68Ga-Trivehexin) Demonstrates Strong Potential for Imaging of αvβ6-Integrin Expression in Pancreatic Cancer Patients

3. trialx.com trialx.com/clinical-trials/listings/250963/safety-of-rad301-in-healthy-human-volunteers-and-patients-with-pancreatic-cancer/

Safety of RAD301 in Healthy Human Volunteers and ... The objective of this clinical trial is to determine the safety of an intravenously administered radioisotope, RAD301 ([68Ga]-Trivehexin), in ...

4. tipranks.com tipranks.com/news/company-announcements/radiopharm-theranostics-rad301-study-a-potential-game-changer-in-cancer-diagnostics

Radiopharm Theranostics' RAD301 Study: A Potential ... The study aims to assess the safety and biokinetics of RAD301, a novel diagnostic agent, in both healthy individuals and those with pancreatic ...

5. withpower.com withpower.com/trial/phase-1-adenocarcinoma-4-2023-b0b16

RAD301 Safety for Pancreatic Cancer The RAD301 medical study, being run by Radiopharm Theranostics, Ltd, is evaluating whether RAD301 will have tolerable side effects & efficacy for patients ...

6. unitedtheranostics.com unitedtheranostics.com/clinical-trials/

Clinical Trials This study is testing a new treatment called RAD301. The goal is to understand how safe RAD301 is and how it behaves in the body. The study includes both ...