Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer or Other Solid T… (NCT05799274) | Clinical Trial Compass
RecruitingPhase 1
Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer or Other Solid Tumors
United States9 participantsStarted 2023-11-09
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
✕. Unable to tolerate the study procedures.
✕. 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 drug administration. An MRI is not required to rule out brain metastases or leptomeningeal metastases
✕. 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, or interfere with the interpretation of study results.
✕. 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.