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

Phase 1

Completed

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

• Registration Number: NCT06416774
• Lead Sponsor: Hexin (Suzhou) Pharmaceutical Technology Co., Ltd

Brief Summary

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.

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 Timeline

• Study Start: 2022-12-29
• Primary Completion: 2023-07-20
• Study Completion: 2023-10-30
• Status Verified: 2024-05
• Study First Submitted: 2024-05-11
• Study First Submitted QC: 2024-05-11
• Last Update Submitted: 2024-05-11
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ib: Patients with malignancy.	68Ga-HX01 Injection(0.07mCi/kg)	The injection dose for phase Ib patients was 0.07 mCi/ kg.
Ia: Low-dose group	68Ga-HX01 Injection(0.05mCi/kg)	The injection dose of 68Ga-HX01 for low-dose group is 0.05 mCi/kg.
Ia: High-dose group.	68Ga-HX01 Injection(0.1mCi/kg)	The injection dose of 68Ga-HX01 for the high-dose group is 0.1 mCi/kg.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The percentage of injected dose per gram (% ID/g)	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 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.
The max uptake of each lesion	At 30 and 60 minutes after 68Ga-HX01 injection.	SUVmax was automatically calculated to quantify 68Ga-HX01 uptake in the lesions.
The mean uptake of each lesion	At 30 and 60 minutes after 68Ga-HX01 injection.	SUVmean was automatically calculated to quantify 68Ga-HX01 uptake in the lesions.
Lesion number	At 30 and 60 minutes after 68Ga-HX01 injection.	Lesion number was recorded.
Dosimetry	At 10, 30, 60 and 120 minutes after 68Ga-HX01 injection.	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.
The size of each lesion	At 30 and 60 minutes after 68Ga-HX01 injection.	Lesion size was recorded.

Trial Locations

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China