Characterizing the Radiochemical and Radiation Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Ductal Adenocarcinoma or Other Solid Tumors
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
• Must be ≥ 18 years of age at the time of informed consent.
• All participants must be willing and able to give informed consent.
• For patients with cancer: 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 12 weeks prior to giving 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, consultation with the Sponsor must be sought prior to patient enrollment. SOC images must be available for submission to the centralized imaging reader as reference.
• Screening laboratory values within 30 days prior to administration of the study drug:
∙ WBC ≥ 1200/μL
‣ ANC ≥ 1000/μL
‣ Platelets ≥ 75,000/μL
‣ Hemoglobin ≥ 9.0 g/dL
‣ Creatinine ≤ 1.5 mg/dL
‣ AST/ALT ≤ 3 x ULN for patients with no liver metastases.
‣ AST/ALT ≤ 5 x ULN for patients with liver metastases.
‣ Bilirubin ≤ 1.5 mg/dL except for participants with Gilbert's disease.
• Patients should have a life expectancy of ≥ 12 weeks as judged by the Investigator.
• All participants must have baseline pulse oximetry ≥ 95% on room air.
• Unremarkable ECGs, with PR intervals of less than 200 msec and QTcF intervals (corrected with Frederica's method) of less than 450 msec.
• Willing to refrain from taking illicit drugs one week prior to PET scanning and through the follow-up phone call on Day 3 (+2 days).
• Willing to refrain from donating blood for 4 weeks after administration of RAD301.
⁃ Have not participated in any other research study that requires taking medication within 4 weeks (or 10 half-lives, whichever is shorter) from the time of informed consent to the end of the Imaging and Safety Follow-Up Period. Previous or ongoing participation in another study should be discussed with the Sponsor.