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

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

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; Ovarian Cancer; Healthy Volunteers; Endometrial Cancer; Non-small Cell Lung Cancer (NSCLC); Pancreatic Ductal Adenocarcinoma; Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Drug: RAD301 ([68Ga]-RAD301)

Detailed Description

This will be 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. The procedures will be similar in both groups, but there could be more scans in healthy volunteers and fewer in individuals with PDAC or Other Solid Tumors during the same time interval if individuals are intolerant of lying still on an imaging table for long periods of time. All individuals will have vital signs, ECGs, and blood for safety assessments collected before and 2 weeks after a single dose, intravenous (IV) administration of the investigational radiopharmaceutical, RAD301, at a dose of 150 ± 50 MBq (~ 4 mCi). There will be 3 whole body (WB) PET-CT and PET scanning sessions.

The initial WB acquisition should take approximately 10 minutes. A subsequent WB PET-only scan will be performed approximately 45 minutes after the injection. As time passes and less radioactivity is localizable to the distal extremities, the scan length may be decreased from vertex-to-thighs. The duration of each scan may increase to partially compensate for radioactive decay. More than one WB scan may be performed in healthy volunteers during the first imaging session, but only one scan will be required in individuals with PDAC or Other Solid Tumors who are not able to tolerate additional scans. The entire first imaging session will last up to approximately 2 hours. The individuals will then be given a rest period (lunch break) after which the sequence of imaging scans could be repeated.

This second imaging session (WB PET-CT) will be optional and depends on the robustness of the individual and the availability of the clinical scanner. The second imaging session will take place mid-day, after the break, and will last up to 1.5 hours.

There will be a third, or final imaging session (WB PET-CT) at the end of the day for all participants, which will strive to include the time interval after approximately 4 physical half-lives of Gallium-68 (Ga-68). The third imaging session will last up to 1.5 hours.

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dimitris Voliotis, MD; Phone Number: +1 646 535 5017; Email: dv@radiopharmtheranostics.com

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Recruiting
      • United Theranostics
      • Contact: Patient Recruitment; Phone Number: 667-HOPENOW; Email: clinicaltrial@unithera.com
  • New York
    • The Bronx, New York, United States, 10461
      • Recruiting
      • Montefiore Medical Center
      • Contact: Gunjan Garg, MD; Phone Number: 718-405-8454; Email: ggarg@montefiore.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion 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.

Exclusion Criteria:

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [68Ga]-RAD301; 150 +/- 50 MBq (~4 mCi) single dose administered at Day 1 visit	Drug: RAD301 ([68Ga]-RAD301); A single dose of 68Ga-RAD301 of 150 +/- 50 MBq (~4mCi) administered as a slow bolus injection over 2-5 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation dosimetry of RAD301	Absorbed radiation dose of RAD301 in critical organs	6 hours
Radiation dosimetry of RAD301	Absorbed radiation dose of RAD301 in tumor lesions	6 hours
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	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 week
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	1 week
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	1 week
Time Activity Curves (TACs)	Percent of the injected activity vs time for selected organs	6 hours
Biokinetics of RAD301	Time lag between injection and peak conspicuity in PDAC tumor masses	6 hours

Collaborators and Investigators

• Sponsor: Radiopharm Theranostics, Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 12, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: endometrial cancer; ovarian cancer; Pancreatic Ductal Adenocarcinoma; cervical cancer; esophageal squamous cell carcinoma; non-small cell lung cancer (NSCLC)
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Respiratory Tract Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Uterine Diseases; Genital Diseases, Female; Lung Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Esophageal Diseases; Lung Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Neoplasms, Squamous Cell; Uterine Cervical Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Uterine Neoplasms; Carcinoma, Squamous Cell; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung; Uterine Cervical Neoplasms; Endometrial Neoplasms
• Other Study ID Numbers: RAD301.2022-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Single center study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No