Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this clinical trial is to determine the safety of an intravenously administered radioisotope, RAD301 ([68Ga]-Trivehexin), in either health volunteers or patients with pancreatic cancer.

All subjects will undergo:

Screening, which entails physical examination and blood samples for standard blood testing.

Subjects that successfully pass screening will undergo:

Gallium-68 PET scanning procedures, which will occur during a single day (about 5-6 hours).

These subjects will return to the clinic at 2 weeks for additional safety labs. All scanned subjects will also be evaluated by telephone follow up on a weekly basis for 1 month after scanning.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Radiopharm Theranostics, Ltd

Criteria

Inclusion Criteria:

1. All subjects must be willing and able to give written informed consent.

2. Healthy 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.

3. Patients with PDAC should be well enough to tolerate the imaging procedures. They should have a history of histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC). Patients may participate regardless of where they are in the course of their illness as long as they seem likely to tolerate the procedures and survive throughout the follow up period.

4. Screening laboratory values within 30 days prior to administration of the study drug:

1. WBC ≥ 3000/µL

2. Neutrophils ≥ 1500/µL

3. Platelets ≥ 75,000>µL

4. Hemoglobin ≥ 9.0 g/dL

5. Creatinine ≤ 1.5 mg/dL

6. AST/ALT ≤ 2.5 x ULN for patients with no liver metastases.

7. AST/ALT ≤ 5 x ULN for patients with liver metastases.

8. Bilirubin ≤ 1.5 mg/dL except for subjects with Gilbert's disease.

5. Patients should have a life expectancy of ≥ 12 weeks as judged by the treating physician.

6. All subjects must have baseline pulse oximetry ≥ 90% on room air.

7. Willing to refrain from taking recreational drugs, including marijuana, and drink less than one unit of alcoholic beverages per day starting one week prior to PET scanning, and avoid taking any recreational substances for the next four weeks after administration of the experimental agent, RAD301.

8. Willing to refrain from donating blood for four (4) weeks before the study and for four (4) weeks after administration of the experimental agent, RAD301.

9. Willing to refrain from participating in any other research study that requires taking medication for four (4) weeks before the study and for four (4) weeks after administration of the experimental agent, RAD301.

10. Willing to refrain from being vaccinated for four (4) weeks before the study and for four (4) weeks after administration of the experimental agent, RAD301.

Exclusion Criteria:

1. Subjects may not be a member of a vulnerable population.

2. Women may not be pregnant or breast feeding. Women of childbearing potential will be excluded unless they have a negative pregnancy test.

3. History suggestive of atopia, as indicated by allergies to multiple medications, foods, and seasonal pollens.

4. History, physical examination, or clinical laboratory tests suggestive of a condition, disorder, or disease that could adversely affect drug absorption, distribution, metabolism, or elimination (ADME) of the tracer, including chronic liver or renal failure.

5. Positive urine toxicology screen for recreational drugs other than marijuana.

6. May not have taken any experimental study drugs in the four (4) weeks prior to PET scanning or for 10 half-lives, whichever is longer.

7. May not have donated blood in the four (4) weeks prior to PET scanning.

8. May not have been vaccinated in the four (4) weeks prior to PET scanning.

9. May not have been exposed to radiation during research producing an Effective Dose (ED) of more than 10 mSv during the last 12 months.

10. Patients with brain metastases are eligible as long as there is no requirement for high doses of systemic corticosteroids that could result in immunosuppression (>10 mg/day prednisone equivalents) for at least 2 weeks prior to study dry administration. An MRI is not required to rule out brain metastases or leptomeningeal metastases.

11. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.

12. Clinically significant cardiovascular/ cerebrovascular disease defined as cerebral vascular accident, stroke, carotid artery disease transient ischemic attach (< 6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class >II) or serious cardiac arrhythmia.

13. Other than PDAC, a prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast.

14. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.

15. Patients who underwent major surgery within 4 weeks of enrollment (not including diagnostic laparoscopy)

16. History of myelodysplastic syndromes or myeloproliferative neoplasms.

17. Abnormal resting hemodynamic function. Systolic blood pressure and pulse must be higher than 110 mmHg and 60 beats per minute while sitting. At the discretion of the investigators, athletic people who seem to be in relatively robust condition may be enrolled if their systolic blood pressure and pulse are higher than 100 mmHg and 50 beats per minute while sitting.

18. Unremarkable electrocardiograms, with PR intervals of less than 200 mSec and QTcF intervals (corrected with Frederica's method) of less than 450 mSec.

19. No NSAIDS for one week prior to PET scanning, including acetaminophen.