RECRUITING

Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer or Other Solid Tumors

Conditions

Healthy Volunteers Pancreatic Ductal Adenocarcinoma Non-small Cell Lung Cancer (NSCLC)Esophageal Squamous Cell Carcinoma Cervical Cancer Endometrial Cancer Ovarian Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Characterizing the Radiochemical and Radiation Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Ductal Adenocarcinoma or Other Solid Tumors

Quick Facts

Study Start:2023-11-09

Study Completion:2025-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05799274

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Must be ≥ 18 years of age at the time of informed consent. 2. All participants must be willing and able to give informed consent. 3. 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. 4. Screening laboratory values within 30 days prior to administration of the study drug: 1. WBC ≥ 1200/μL 2. ANC ≥ 1000/μL 3. Platelets ≥ 75,000/μL 4. Hemoglobin ≥ 9.0 g/dL 5. Creatinine ≤ 1.5 mg/dL 6. AST/ALT ≤ 3 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 participants with Gilbert's disease. 5. Patients should have a life expectancy of ≥ 12 weeks as judged by the Investigator. 6. All participants must have baseline pulse oximetry ≥ 95% on room air. 7. Unremarkable ECGs, with PR intervals of less than 200 msec and QTcF intervals (corrected with Frederica's method) of less than 450 msec. 8. 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). 9. Willing to refrain from donating blood for 4 weeks after administration of RAD301. 10. 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.	1. 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. 2. 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. 3. History of an anaphylactic reaction to a protein- or peptide-derived therapeutic or a diagnostic agent. 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 of RAD301, including chronic liver or renal failure. 5. Unable to tolerate the study procedures. 6. 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 7. 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. 8. 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. 9. 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 bladder cancer, or carcinoma in situ of the prostate, cervix or breast. 10. 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 not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. 11. Participants who underwent major surgery within 4 weeks of administration of study drug (not including diagnostic laparoscopy).

Inclusion Criteria

Exclusion Criteria

1. Must be ≥ 18 years of age at the time of informed consent.
2. All participants must be willing and able to give informed consent.
3. 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.
4. Screening laboratory values within 30 days prior to administration of the study drug:
1. WBC ≥ 1200/μL
2. ANC ≥ 1000/μL
3. Platelets ≥ 75,000/μL
4. Hemoglobin ≥ 9.0 g/dL
5. Creatinine ≤ 1.5 mg/dL
6. AST/ALT ≤ 3 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 participants with Gilbert's disease.
5. Patients should have a life expectancy of ≥ 12 weeks as judged by the Investigator.
6. All participants must have baseline pulse oximetry ≥ 95% on room air.
7. Unremarkable ECGs, with PR intervals of less than 200 msec and QTcF intervals (corrected with Frederica's method) of less than 450 msec.
8. 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).
9. Willing to refrain from donating blood for 4 weeks after administration of RAD301.
10. 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.

1. 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.
2. 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.
3. History of an anaphylactic reaction to a protein- or peptide-derived therapeutic or a diagnostic agent.
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 of RAD301, including chronic liver or renal failure.
5. Unable to tolerate the study procedures.
6. 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
7. 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.
8. 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.
9. 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 bladder cancer, or carcinoma in situ of the prostate, cervix or breast.
10. 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 not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
11. Participants who underwent major surgery within 4 weeks of administration of study drug (not including diagnostic laparoscopy).

Contacts and Locations

Study Contact

Dimitris Voliotis, MD

CONTACT

+1 646 535 5017

dv@radiopharmtheranostics.com

Study Locations (Sites)

United Theranostics

Princeton, New Jersey, 08540

United States

Montefiore Medical Center

The Bronx, New York, 10461

United States

Collaborators and Investigators

Sponsor: Radiopharm Theranostics, Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-09

Study Completion Date2025-11

Study Record Updates

Study Start Date2023-11-09

Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

Pancreatic Ductal Adenocarcinoma
non-small cell lung cancer (NSCLC)
esophageal squamous cell carcinoma
cervical cancer
endometrial cancer
ovarian cancer

Additional Relevant MeSH Terms

Healthy Volunteers
Pancreatic Ductal Adenocarcinoma
Non-small Cell Lung Cancer (NSCLC)
Esophageal Squamous Cell Carcinoma
Cervical Cancer
Endometrial Cancer
Ovarian Cancer