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

Clear Cell Renal Cell Carcinoma Clinical Trial

— ZIRDOSE-CP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05861778
• Other study ID #: TLX250CDx-CP-001
• Status: Completed
• Phase: Phase 1
• Start date: June 26, 2023
• Est. completion date: November 27, 2023

Study information

• Verified date: December 2023
• Source: Telix International Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 27, 2023
• Est. primary completion date: November 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Voluntarily signed written informed consent

2. Chinese male or female=18 years old.

3. 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

4. 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.

5. Expected survival = 6 months.

6. Agree to follow appropriate and highly effective contraception method for at least 35 days after the administration of 89Zr-TLX250.

Exclusion Criteria:

1. Renal mass is known to be a metastasis of another primary tumor.

2. Have other malignancies that require treatment.

3. Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).

4. 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]).

5. Exposure to murine or chimeric antibodies within the last 5 years.

6. Prior use of radionuclides with an interval of less than 10 halflives.

7. 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.

8. Renal insufficiency with glomerular filtration rate (GFR) = 60 mL/min/1.73 m².

9. Uncontrolled psychiatric disorders.

10. Women who are pregnant or breastfeeding.

11. Known hypersensitivity to girentuximab or DFO (deferoxamine).

12. 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.

13. Vulnerable population (e.g., being in detention).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma
• Recurrence
• Recurrent Renal Cell Cancer

Intervention

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.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital & Institute	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Telix International Pty Ltd	Grand Pharmaceutical (China) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety parameter Physical Examination	Frequency of occurrence and severity of abnormal findings in safety investigations regarding the physical examination.	9 days
Primary	Safety parameter Vital Signs	Frequency of occurrence and severity of abnormal findings in safety investigations regarding the Vital signs	9 days
Primary	Safety parameter Laboratory examinations	Frequency of occurrence and severity of abnormal findings in safety investigations regarding Laboratory examinations.	9 days
Primary	Safety parameter concomitant medications	Frequency of occurrence and severity of abnormal findings in safety investigations regarding concomitant medications.	9 days
Primary	Safety parameter ECG	Frequency of occurrence and severity of abnormal findings in the 12-lead ECG (ECG QT Interval)	9 days
Secondary	Whole blood radioactivity PK parameters	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)	6 days
Secondary	Radiation 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, using low dose CT without contrast agent. Normalized Absorbed Dose = Absorbed Dose/ Administered Dose	8 days
Secondary	Tumour dosimetry	Normalised whole body effective radiation dose (mSv/MBq)	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