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.
WBC ≥ 1200/μL
Participant may not be a member of a vulnerable population defined as participants who are not able to understand the nature of the trial and provide informed consent or who have any medical, psychological or sociological condition that in the opinion of the investigator would interfere with the ability to give consent or interfere with protocol compliance.
Women may not be pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to administration of RAD301.
History of an anaphylactic reaction to a protein- or peptide-derived therapeutic or a diagnostic agent.
History, physical examination, or clinical laboratory tests suggestive of a condition, disorder, or disease that could adversely affect drug absorption, distribution, metabolism, or elimination of RAD301, including chronic liver or renal failure.
Single group
RAD301 ([68Ga]-RAD301)
DrugA single dose of 68Ga-RAD301 of 150 +/- 50 MBq (\~4mCi) administered as a slow bolus injection over 2-5 minutes
Radiation dosimetry of RAD301
Absorbed radiation dose of RAD301 in critical organs
Radiation dosimetry of RAD301
Absorbed radiation dose of RAD301 in tumor lesions
Safety and tolerability of RAD301
The properties, incidence, nature and severity of AEs and SAEs per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Concordance between RAD301 PET and CT or MRI
Proportion of metastases correctly identified by RAD301 out of the total number of metastases confirmed by standard of care (SOC) imaging methods, such as computed tomography (CT) or MRI
Concordance between RAD301 PET and CT or MRI
Proportion of cases correctly identified by RAD301 as having no metastasis out of the total number of cases confirmed to have no metastasis by SOC imaging methods, such as CT or MRI
Concordance of RAD301 PET and CT or MRI
Proportion of all cases correctly identified by RAD301, either as having or not having metastasis, out of the total number of cases, as confirmed by SOC imaging methods, such as CT or MRI
Time Activity Curves (TACs)
Percent of the injected activity vs time for selected organs
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