ZIRDOSE-CP: Evaluation of 89Zr-TLX250 PET/CT in Chinese Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma

Sponsor

Telix International Pty Ltd (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05861778

Collaborator

Grand Pharmaceutical (China) Co., Ltd. (Other)

Enrollment

Arm

10.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The study is designed to evaluate the safety, tolerability, radiation dosimetry and pharmacokinetics 89Zr-TLX250 (also known as 89Zr-DFO-girentuximab) Positron Emission Tomography/Computed Tomography (PET/CT) in adult Chinese patients with indeterminate renal masses or Suspected Recurrent Renal Clear Cell Carcinoma

Condition or Disease	Intervention/Treatment	Phase
Clear Cell Renal Cell Carcinoma Suspected Recurrent Renal Clear Cell Carcinoma Recurrent Renal Cell Cancer	Drug: 89Zr-Girentuximab	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

An Open-label, Phase I Study to Evaluate the Safety, Radiation Dosimetry and Pharmacokinetics of 89Zr-TLX250 PET/CT in Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma

Anticipated Study Start Date :

May 29, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Apr 24, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 89Zr-girentuximab A single administration of 37 MBq (+/-10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab	Drug: 89Zr-Girentuximab A single administration of 37 MBq (±10%) 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab, followed by whole body PET/CT scans were performed at 0.5h, 4h, 24h, 72 hours and 7±1 days post administration. Other Names: 89Zr-DFO-girentuximab 89Zr-TLX250 TLX250CDx

Arm

Intervention/Treatment

Experimental: 89Zr-girentuximab

A single administration of 37 MBq (+/-10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab

Drug: 89Zr-Girentuximab

A single administration of 37 MBq (±10%) 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab, followed by whole body PET/CT scans were performed at 0.5h, 4h, 24h, 72 hours and 7±1 days post administration.

Other Names:

89Zr-DFO-girentuximab

89Zr-TLX250

TLX250CDx

Outcome Measures

Primary Outcome Measures

Safety parameter Physical Examination [9 days]
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the physical examination.
Safety parameter Vital Signs [9 days]
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the Vital signs
Safety parameter Laboratory examinations [9 days]
Frequency of occurrence and severity of abnormal findings in safety investigations regarding Laboratory examinations.
Safety parameter concomitant medications [9 days]
Frequency of occurrence and severity of abnormal findings in safety investigations regarding concomitant medications.
Safety parameter ECG [9 days]
Frequency of occurrence and severity of abnormal findings in the 12-lead ECG (ECG QT Interval)

Secondary Outcome Measures

Whole blood radioactivity PK parameters [6 days]
This outcome will be measured by analysing the radioactivity present in the blood at baseline (pre-dose), 0.5h, 1h, 2h, 4h, 24h, 72h and Day 5+/-1 day. Assessments include: Cmax (maximum concentration)
Whole blood radioactivity PK parameters [6 days]
This outcome will be measured by analysing the radioactivity present in the blood at baseline (pre-dose), 0.5h, 1h, 2h, 4h, 24h, 72h and Day 5+/-1 day. Assessments include: tmax (time to maximum concentration)
Whole blood radioactivity PK parameters [6 days]
This outcome will be measured by analysing the radioactivity present in the blood at baseline (pre-dose), 0.5h, 1h, 2h, 4h, 24h, 72h and Day 5+/-1 day. Assessments include AUC0-inf (area under the concentration-time curve from 0 to inf)
Whole blood radioactivity PK parameters [6 days]
This outcome will be measured by analysing the radioactivity present in the blood at baseline (pre-dose), 0.5h, 1h, 2h, 4h, 24h, 72h and Day 5+/-1 day. Assessments include: t1/2 (elimination halflife),
Whole blood radioactivity PK parameters [6 days]
This outcome will be measured by analysing the radioactivity present in the blood at baseline (pre-dose), 0.5h, 1h, 2h, 4h, 24h, 72h and Day 5+/-1 day. Assessments include: λz (terminal elimination rate constant
Whole blood radioactivity PK parameters [6 days]
This outcome will be measured by analysing the radioactivity present in the blood at baseline (pre-dose), 0.5h, 1h, 2h, 4h, 24h, 72h and Day 5+/-1 day. Assessments include: CLt (total body clearance)
Whole blood radioactivity PK parameters [6 days]
This outcome will be measured by analysing the radioactivity present in the blood at baseline (pre-dose), 0.5h, 1h, 2h, 4h, 24h, 72h and Day 5+/-1 day. Assessments include: , Vdz (volume of distribution).
Radiation dosimetry [8 days]
whole body PET/CT scans will be acquired in supine position at 0.5, 4, 24, 72 and 168±24 h (Day 7±1) post injection, using low dose CT without contrast agent. Normalized Absorbed Dose = Absorbed Dose/ Administered Dose
Tumour dosimetry [Whole body PET/CT scans will be acquired in supine position at 0.5, 4, 24, 72 and 168±24 h (Day 7±1) post injection]
Normalised whole body effective radiation dose (mSv/MBq)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Voluntarily signed written informed consent
Chinese male or female≥18 years old.
Have an indeterminate renal mass, suspected renal cell carcinoma, or previously diagnosed ccRCC, suspected recurrence on the pre-screening imaging from Day -90 to Day -1
Negative serum pregnancy test for female subjects of childbearing potential at screening. Confirmed negative urine pregnancy test within 24 hours prior to administration of investigational product.
Expected survival ≥ 6 months.
Agree to follow appropriate and highly effective contraception method for at least 35 days after the administration of 89Zr-TLX250.

Exclusion Criteria:

Renal mass is known to be a metastasis of another primary tumor.
Have other malignancies that require treatment.
Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or such therapy resulted in a persistent adverse event (> Grade 1) (per National Cancer Institute-Common Toxicity Criteria version 5.0 [NCICTCAE v5.0]).
Exposure to murine or chimeric antibodies within the last 5 years.
Prior use of radionuclides with an interval of less than 10 halflives.
Exposure to any investigational diagnostic or therapeutic agent within the first 4 weeks or 5 half-lives (whichever is longer) of the planned administration of 89Zr-TLX250.
Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m².
Uncontrolled psychiatric disorders.
Women who are pregnant or breastfeeding.
Known hypersensitivity to girentuximab or DFO (deferoxamine).
Have a serious non-malignant disease (e.g., infectious disease, autoimmune disease, or metabolic disease) that, in the opinion of the investigator, may interfere with the purpose of the study or subject safety or compliance.
Vulnerable population (e.g., being in detention).