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Tests treatment safety and results for Healthy Volunteers
Official title Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer or Other Solid Tumors
ClinicalTrials.gov ID: NCT05799274
What this study is testing
What is RAD301 ([68Ga]-RAD301)?
RAD301 ([68Ga]-RAD301) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for healthy volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Screening laboratory values within 30 days prior to administration of the study drug:
- WBC ≥ 1200/μL
You likely can't join if
- 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...
- Women may not be pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to...
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Clinically significant cardiovascular/ cerebrovascular disease defined as cerebral vascular accident, stroke, carotid artery disease transient ischemic attach (\ II) or serious cardiac arrhythmia.
- Other than the tumor types being studied, 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...
- Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis...
- Participants who underwent major surgery within 4 weeks of administration of study drug (not including diagnostic laparoscopy).
The study team makes the final eligibility decision.
Where it's taking place
- Princeton, New Jersey, United States
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Princeton, New Jersey, United States; The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.