A Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer

A Phase I/IIa Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer

Phase I/II study in the management of Healthy Male Subjects and patients with suspected prostate cancer.

Study Overview

• Status: Completed
• Conditions: Healthy Male Subjects; Suspected Prostate Cancer
• Intervention / Treatment: Drug: INR101; Drug: INR101

Detailed Description

A multi-center, prospective, open-label, randomized Phase I/II diagnostic study designed for the management of healthy male subjects and patients with suspected prostate cancer.

Phase I Study Objective: The primary goal is to assess the biodistribution, dosimetry, pharmacokinetic (PK) attributes, and safety profile of INR101 injections in healthy Chinese male subjects. The specific endpoints include evaluating the safety, Standardized Uptake Value (SUV), Accumulation (%ID), Retention Time, Absorbed Dose, Effective Dose, and PK parameters in whole blood, plasma, and urine following an intravenous administration of INR101.

Phase II Study Objective: This phase aims to determine the diagnostic efficacy of INR101 injection PET/CT scans in patients with suspected prostate cancers. The principal aim is to ascertain the optimal imaging conditions, which involve determining the best dose and timing of administration. This will be gauged based on the diagnostic performance metrics-sensitivity, specificity, and accuracy-of the INR101 injection PET/CT at different dosages and imaging intervals, using prostate biopsy pathology results as the reference standard.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 100088
      • Yunhe Pharmaceutical (Tianjin) Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Phase 1 Inclusion Criteria:

1. Males aged ≥18 years old
2. Good health status or no major illness, judged by the investigator based on the following assessments: medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests that are normal or abnormal but not clinically significant
3. Agree to use contraceptive measures from the day of signing the informed consent form until 3 months after drug administration, to avoid sperm donation;
4. The subjects/legally authorized representative/guardian understands the purpose and procedures of the trial, and signs the informed consent form.

Phase 2 Inclusion Criteria:

1. Males aged ≥18 years
2. ECOG score of 0 or 1
3. Subjects who are planned to undergo prostate biopsy for pathological examination after clinical assessment, with no contraindications for biopsy
4. Routine blood tests, liver and kidney function, and coagulation function meet the corresponding conditions
5. Agree to use contraceptive measures from the date of signing the informed consent form to 3 months after medication administration, to avoid sperm donation
6. The subject/legal authorized representative/guardian understands the purpose and procedures of the trial and signs the informed consent form

Phase 1 Exclusion Criteria:

1. Subjects who cannot complete INR101 imaging according to the requirements
2. Subjects who cannot complete pharmacokinetics sample collection according to the requirements
3. Serum virology examination (Heptitis B surface antigen,Anti-Treponema pallidum antibody,HIV antibodies,Antibody to Hepatitis C Virus) is abnormal, which is judged by the researchers to have clinical significance
4. History of mental illness
5. History of past malignant tumors
6. History of past heart-related diseases
7. History of significant brain diseases in the past
8. Suffering from severe and/or poorly controlled and/or unstable diseases that the researcher judges may affect the study
9. History of bleeding or coagulation disorders
10. History of alcohol abuse or drug abuse/dependency
11. Known allergy to the active ingredients of INR101 or its components
12. Participated in other clinical trials before screening or during screening, or plans to participate in other clinical trials during this study
13. The researcher judges that there are any medical diseases or other conditions that may affect safety, compliance or may affect the results of the study

Phase 2 Exclusion Criteria:

1. Subjects who are unable to complete the INR101 imaging as required
2. History of any other malignant tumors in the past
3. Subjects in other interventional clinical trials or subjects in clinical trials of radioactive therapeutic drugs before signing the informed consent form
4. Receiving any anti-tumor treatment before drug administration
5. Known allergy to the active ingredients of INR101 or its components Abnormal serum virology examination
6. Researchers judge that there are any medical diseases or other conditions that may affect safety, compliance or may affect the study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: phase I; Experimental: INR101 PET/ CT Drug: INR101.	Drug: INR101; • 9±1 mCi of INR101 will be injected intravenously prior to perform the PET/CT; Other Names: INR101 PET CT; Drug: INR101; 9±1 mCi of INR101 will be injected intravenously prior to perform the PET/CT; 7±1 mCi of INR101 will be injected intravenously prior to perform the PET/CT; Other Names: INR101 PET CT
Experimental: phase II; Experimental: INR101 PET/ CT Interventions: Drug: INR101	Drug: INR101; • 9±1 mCi of INR101 will be injected intravenously prior to perform the PET/CT; Other Names: INR101 PET CT; Drug: INR101; 9±1 mCi of INR101 will be injected intravenously prior to perform the PET/CT; 7±1 mCi of INR101 will be injected intravenously prior to perform the PET/CT; Other Names: INR101 PET CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase I primary outcome: incidence of adverse events of INR101 injection	Treatment-emergent adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	7 days after administration
Phase I primary outcome:radiation dosimetry	Mean absorbed radiation doses were estimated using the source and target organ framework. Eight health subjects underwent serial INR 101 PET/CT scans at three time points following radiotracer injection: 5±5 min，30±5 min，60±10 min，120±10 min，180±20 min.	3 hours after administration
Phase I primary outcome:Tmax (Time to reach maximum plasma concentration)	Assessment of INR101 Tmax in whole blood 4 hours after administration	4 hours after administration
Phase I primary outcome:t1/2 (Elimination half-life)	Assessment of INR101 t1/2 in whole blood 4 hours after administration	4 hours after administration
Phase I primary outcome:AUC0-t (Area under the plasma concentration-time curve from time 0 to time t)	Assessment of INR101 AUC0-t in whole blood 4 hours after administration	4 hours after administration
Phase I primary outcome:AUC0-∞ (Area under the plasma concentration-time curve from time 0 to infinity)	Assessment of INR101 AUC0-∞ in whole blood 4 hours after administration	4 hours after administration
Phase I primary outcome:CL (Clearance)	Assessment of INR101 CL in whole blood 4 hours after administration	4 hours after administration
Phase I primary outcome:Cmax (Maximum plasma concentration)	Assessment of INR101 Cmax in whole blood 4 hours after administration	4 hours after administration
Phase I primary outcome:SUV-standardized uptake value	Assessment of INR101 uptake by PET scan by measuring standardized uptake value in the target organs.	3 hours after administration
Phase I primary outcome:%ID/g - percentage of injected dose per gram	Assessment of INR101 uptake by PET scan by measuring percentage of injected dose per gram of tissue in the target organs	3 hours after administration
Phase I primary outcome:residence time - residence time in the the target organs	Assessment of INR101 uptake by PET scan by measuring residence time in the target organs	3 hours after administration
Phase II primary outcome :diagnostic efficacy	The sensitivity, specificity, and accuracy of INR101 PET/CT	28 days after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase II secondary outcome: Incidence of adverse events of INR101 injection	Treatment-emergent adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	7 days after administration

Collaborators and Investigators

• Sponsor: Yunhe Pharmaceutical (Tianjin) Co., Ltd
• Investigators: Principal Investigator: Jinming Zhang, Ph.D, The First Medical Center of the General Hospital of the Chinese People's Liberation Army; Principal Investigator: Jigang Yang, Ph.D, Beijing Friendship Hospital; Principal Investigator: Fugeng Liu, BD, Beijing Hospital; Principal Investigator: Xuejuan Wang, Ph.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): October 10, 2024

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: INR101-I/IIa-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No