A Clinical Study of 68Ga-HX01 Injection for PET Imaging

A Phase I Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dose and Pharmacokinetics of 68Ga-HX01 Injection for PET Imaging

This is a single-center, open Phase I clinical study, consisting of two parts: a Phase Ia study in healthy adult subjects and a Phase Ib study in patients with malignant solid tumors.

Study Overview

• Status: Completed
• Conditions: Healthy; Malignancy
• Intervention / Treatment: Drug: 68Ga-HX01 Injection(0.05mCi/kg); Drug: 68Ga-HX01 Injection(0.1mCi/kg); Drug: 68Ga-HX01 Injection(0.07mCi/kg)

Detailed Description

Phase Ia design:

The Phase Ia study is designed to evaluate the safety, biodistribution (PET imaging), radiation dose, and pharmacokinetics of 68Ga-HX01 injection after a single intravenous administration in healthy Chinese adult subjects.

Twelve healthy adult subjects will be enrolled in the Phase Ia program.

Phase Ib design:

The purpose of the Phase Ib clinical study is to evaluate the safety and biodistribution (PET imaging) of patients with malignant solid tumors receiving a single intravenous administration of 68Ga-HX01 injection, and to explore the characteristics of tumor imaging.

Ten patients with malignant solid tumors will be enrolled in Phase Ib.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

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

Description

This study consists of two parts: a Phase Ia study in healthy adult subjects and a Phase Ib study in patients with malignant solid tumors.

Phase Ia:

Inclusion Criteria:

• 18-50 years old;
• Female weight 45-80kg, male weight 50-80kg;
• Agree to take effective contraception during the study and for at least three months after the drug administration.

Exclusion Criteria:

• Pregnant or lactating women; Or plan to donate sperm or eggs during the study or within three months after drug administration;
• Known or suspected allergic to the test drug or any of its components;
• Receiving another investigational drug at the time of enrollment, or within 5 half-lives of the drug at the time of enrollment;
• Those who tested positive for hepatitis B/C virus, syphilis or HIV during screening;
• Clinically significant abnormalities in hematology, blood biochemistry, and urine routine during screening;
• Patients with clinically significant diseases within 4 weeks before screening;
• Blood pressure higher than 150/100 mmHg or lower than 90/50 mmHg at screening;
• Use of any prescription or over-the-counter drugs within 2 weeks before the trial drug administration;
• Blood donation or blood loss ≥500 mL within 12 weeks before administration;
• History of drug or alcohol abuse within 12 months prior to administration;
• Smoking more than 5 cigarettes a day or consuming the same amount of nicotine or nicotine replacement within 3 months before administration;
• History of malignancy;
• Plan to schedule surgery and other invasive interventions within one week of the test drug injection;
• Compliance to lie for about 90 minutes during the PET examination.

Phase Ib:

Inclusion Criteria:

• Patients with malignant solid tumors with measurable lesions (target lesions) confirmed by histopathology or cytology or clinical diagnosis;
• 18-75 years old;
• Eastern Cooperative Oncology Group (ECOG) score 0 or 1;
• life expectancy ≥6 months;
• Agree to take effective contraception during the study and for at least three months after the drug administration.

Exclusion Criteria:

• Pregnant or lactating women; Or plan to donate sperm or eggs during the study or within three months after drug administration;
• Known or suspected allergic to the test drug or any of its components;
• Receiving another investigational drug at the time of enrollment, or within 5 half-lives of the drug at the time of enrollment;
• Those who tested positive for hepatitis B/C virus, syphilis or HIV during screening;
• Any radiotherapeutic drugs used within 90 days before administration, or any radionuclide diagnostic drugs received within 3 days before administration;
• Plan to schedule surgery and other invasive interventions within 2 days after trial drug injection;
• Abnormal liver and kidney function: serum total bilirubin (TBIL) > 1.5×ULN (upper limit of normal), or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5×ULN, or serum creatinine > 1.5×ULN;
• With active infection at the time of screening;
• Compliance to lie for about 60 minutes during the PET examination.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ia: Low-dose group; The injection dose of 68Ga-HX01 for low-dose group is 0.05 mCi/kg.	Drug: 68Ga-HX01 Injection(0.05mCi/kg); The study is divided into three stages, including screening period, administration period and follow-up observation period. The maximum screening period is 7 days. Eligible subjects will receive intravenous injection of the experimental drug 68Ga-HX01 on Day 1 of the study and undergo PET imaging, while blood and urine are collected for radioactive counts for pharmacokinetic analysis and safety monitoring. They will return to the study center for safety checks on Day 2 after injection and phone follow-up on Day 7 for adverse events and drug combinations/treatments.; Other Names: 68Ga-HX01
Experimental: Ia: High-dose group.; The injection dose of 68Ga-HX01 for the high-dose group is 0.1 mCi/kg.	Drug: 68Ga-HX01 Injection(0.1mCi/kg); The study is divided into three stages, including screening period, administration period and follow-up observation period. The maximum screening period is 7 days. Eligible subjects will receive intravenous injection of the experimental drug 68Ga-HX01 on Day 1 of the study and undergo PET imaging, while blood and urine are collected for radioactive counts for pharmacokinetic analysis and safety monitoring. They will return to the study center for safety checks on Day 2 after injection and phone follow-up on Day 7 for adverse events and drug combinations/treatments.; Other Names: 68Ga-HX01
Experimental: Ib: Patients with malignancy.; The injection dose for phase Ib patients was 0.07 mCi/ kg.	Drug: 68Ga-HX01 Injection(0.07mCi/kg); The study is divided into three stages, including screening period, administration period and follow-up observation period. The maximum screening period is 7 days. Eligible subjects will receive intravenous injection of the experimental drug 68Ga-HX01 on Day 1 of the study and undergo PET imaging, while blood and urine are collected for safety monitoring. They will return to the study center for safety checks on Day 2 after injection and phone follow-up on Day 7 for adverse events and drug combinations/treatments.; Other Names: 68Ga-HX01

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature	Changes in body temperature after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on body temperature.	During the screening period (within 7 days), within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Respiration	Changes in respiration rate after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on respiration.	Time Frame: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Pulse	Changes in pulse after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on pulse.	During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Blood pressure	Changes in diastolic pressure and systolic pressure after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on blood pressure.	During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Oxygen saturation	Changes in oxygen saturation after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on oxygen saturation.	During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Electrocardiogram QT Interval	Electrocardiogram QT interval was recorded to assess the effect of 68Ga-HX01 administration.	Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
Electrocardiogram QRS Interval	Electrocardiogram QRS interval was recorded to assess the effect of 68Ga-HX01 administration.	Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
Electrocardiogram PR Interval	Electrocardiogram PR interval was recorded to assess the effect of 68Ga-HX01 administration.	Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
Electrocardiogram T Wave	The shape of electrocardiogram T wave was recorded to assess the effect of 68Ga-HX01 administration.	Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
Electrocardiogram ST Segment	The shape of electrocardiogram ST segment was recorded to assess the effect of 68Ga-HX01 administration.	Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
Number of Participants With Abnormal Laboratory Values in Blood routine	The blood routine of Day 2 was recorded.	Day 2.
Number of Participants With Abnormal Laboratory Values in Blood biochemistry	Blood biochemistry of Day 2 was recorded.	Day 2.
Prothrombin time test and/or a partial thromboplastin time test (PTT)	Coagulation function of Day 2 was recorded.	Day 2.
Number of Participants With Abnormal Laboratory Values in Urine routine	Urine routine of Day 2 was recorded.	Day 2.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosimetry	OLINDA/EXM software was used to calculate the radiation dose using the uptake of each organ and tissue in Ia subjects. The uptake values are calculated from the SUV values of PET images at each time point.	At 10, 30, 60 and 120 minutes after 68Ga-HX01 injection.
The percentage of injected dose per gram (% ID/g)	The blood radioactivity time-activity curve was drawn based on the percentage of injected dose per gram (% ID/g) of blood samples at each time point.	Blood samples are collected for the radioactivity determination before (within 30 minutes) and after 68Ga-HX01 injection at different time points (2, 5, 10, 30, 60, 90, 120, and 180 minutes).
The max uptake of each lesion	SUVmax was automatically calculated to quantify 68Ga-HX01 uptake in the lesions.	At 30 and 60 minutes after 68Ga-HX01 injection.
The mean uptake of each lesion	SUVmean was automatically calculated to quantify 68Ga-HX01 uptake in the lesions.	At 30 and 60 minutes after 68Ga-HX01 injection.
Lesion number	Lesion number was recorded.	At 30 and 60 minutes after 68Ga-HX01 injection.
The size of each lesion	Lesion size was recorded.	At 30 and 60 minutes after 68Ga-HX01 injection.

Collaborators and Investigators

• Sponsor: Hexin (Suzhou) Pharmaceutical Technology Co., Ltd
• Collaborators: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2022
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: May 11, 2024
• First Submitted That Met QC Criteria: May 11, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 11, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: XLan-0688

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