## Protocol Section
### Identification Module
**NCT ID:** NCT06416774

**Brief Title:** A Clinical Study of 68Ga-HX01 Injection for PET Imaging

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

#### Organization Study ID Info
**ID:** XLan-0688
#### Organization
**Class:** INDUSTRY
**Full Name:** Hexin (Suzhou) Pharmaceutical Technology Co., Ltd
### Status Module
#### Completion Date
**Date:** 2023-10-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-07-20

**Type:** ACTUAL

#### Start Date
**Date:** 2022-12-29

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-11
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Wuhan Union Hospital, China

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hexin (Suzhou) Pharmaceutical Technology Co., Ltd

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Healthy

- Malignancy

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 22

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The injection dose of 68Ga-HX01 for low-dose group is 0.05 mCi/kg.

**Intervention Names:**

- Drug: 68Ga-HX01 Injection(0.05mCi/kg)

**Label:** Ia: Low-dose group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The injection dose of 68Ga-HX01 for the high-dose group is 0.1 mCi/kg.

**Intervention Names:**

- Drug: 68Ga-HX01 Injection(0.1mCi/kg)

**Label:** Ia: High-dose group.

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** The injection dose for phase Ib patients was 0.07 mCi/ kg.

**Intervention Names:**

- Drug: 68Ga-HX01 Injection(0.07mCi/kg)

**Label:** Ib: Patients with malignancy.

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Ia: Low-dose group

**Description:** 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.

**Name:** 68Ga-HX01 Injection(0.05mCi/kg)

**Other Names:**

- 68Ga-HX01

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Ia: High-dose group.

**Description:** 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.

**Name:** 68Ga-HX01 Injection(0.1mCi/kg)

**Other Names:**

- 68Ga-HX01

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Ib: Patients with malignancy.

**Description:** 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.

**Name:** 68Ga-HX01 Injection(0.07mCi/kg)

**Other Names:**

- 68Ga-HX01

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Changes in body temperature after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on body temperature.

**Measure:** Temperature

**Time Frame:** 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.

**Description:** Changes in respiration rate after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on respiration.

**Measure:** Respiration

**Time Frame:** 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.

**Description:** Changes in pulse after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on pulse.

**Measure:** Pulse

**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.

**Description:** Changes in diastolic pressure and systolic pressure after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on blood pressure.

**Measure:** Blood pressure

**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.

**Description:** Changes in oxygen saturation after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on oxygen saturation.

**Measure:** Oxygen saturation

**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.

**Description:** Electrocardiogram QT interval was recorded to assess the effect of 68Ga-HX01 administration.

**Measure:** Electrocardiogram QT Interval

**Time Frame:** Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.

**Description:** Electrocardiogram QRS interval was recorded to assess the effect of 68Ga-HX01 administration.

**Measure:** Electrocardiogram QRS Interval

**Time Frame:** Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.

**Description:** Electrocardiogram PR interval was recorded to assess the effect of 68Ga-HX01 administration.

**Measure:** Electrocardiogram PR Interval

**Time Frame:** Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.

**Description:** The shape of electrocardiogram T wave was recorded to assess the effect of 68Ga-HX01 administration.

**Measure:** Electrocardiogram T Wave

**Time Frame:** Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.

**Description:** The shape of electrocardiogram ST segment was recorded to assess the effect of 68Ga-HX01 administration.

**Measure:** Electrocardiogram ST Segment

**Time Frame:** Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.

**Description:** The blood routine of Day 2 was recorded.

**Measure:** Number of Participants With Abnormal Laboratory Values in Blood routine

**Time Frame:** Day 2.

**Description:** Blood biochemistry of Day 2 was recorded.

**Measure:** Number of Participants With Abnormal Laboratory Values in Blood biochemistry

**Time Frame:** Day 2.

**Description:** Coagulation function of Day 2 was recorded.

**Measure:** Prothrombin time test and/or a partial thromboplastin time test (PTT)

**Time Frame:** Day 2.

**Description:** Urine routine of Day 2 was recorded.

**Measure:** Number of Participants With Abnormal Laboratory Values in Urine routine

**Time Frame:** Day 2.

#### Secondary Outcomes

**Description:** 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.

**Measure:** Dosimetry

**Time Frame:** At 10, 30, 60 and 120 minutes after 68Ga-HX01 injection.

**Description:** 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.

**Measure:** The percentage of injected dose per gram (% ID/g)

**Time Frame:** 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).

**Description:** SUVmax was automatically calculated to quantify 68Ga-HX01 uptake in the lesions.

**Measure:** The max uptake of each lesion

**Time Frame:** At 30 and 60 minutes after 68Ga-HX01 injection.

**Description:** SUVmean was automatically calculated to quantify 68Ga-HX01 uptake in the lesions.

**Measure:** The mean uptake of each lesion

**Time Frame:** At 30 and 60 minutes after 68Ga-HX01 injection.

**Description:** Lesion number was recorded.

**Measure:** Lesion number

**Time Frame:** At 30 and 60 minutes after 68Ga-HX01 injection.

**Description:** Lesion size was recorded.

**Measure:** The size of each lesion

**Time Frame:** At 30 and 60 minutes after 68Ga-HX01 injection.

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Wuhan

**Country:** China

**Facility:** Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

**State:** Hubei

**Zip:** 430022

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
