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

NCT05799274 | Recruiting Phase 1 FDA Drug

• 1 other identifier: RAD301.2022-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Concordance between RAD301 PET and CT or MRI

  1 week

• Concordance between RAD301 PET and CT or MRI

  1 week

• Concordance of RAD301 PET and CT or MRI

  1 week

Study Arms (1)

[68Ga]-RAD301

EXPERIMENTAL

150 +/- 50 MBq (\~4 mCi) single dose administered at Day 1 visit

Drug: RAD301 ([68Ga]-RAD301)

Interventions

RAD301 ([68Ga]-RAD301) DRUG

A single dose of 68Ga-RAD301 of 150 +/- 50 MBq (\~4mCi) administered as a slow bolus injection over 2-5 minutes

[68Ga]-RAD301

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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
• 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.

You may not qualify 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 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.
• 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.
• 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.
• Participants who underwent major surgery within 4 weeks of administration of study drug (not including diagnostic laparoscopy).

Sponsors & Collaborators

• Radiopharm Theranostics, Ltd: lead

Study Sites (2)

United Theranostics

Princeton, New Jersey, 08540, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Esophageal Squamous Cell Carcinoma; Uterine Cervical Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Dimitris Voliotis, MD

CONTACT

+1 646 535 5017; dv@radiopharmtheranostics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: April 5, 2023
• Study Start: November 9, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)