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

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

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

Study Overview

• Status: Completed
• Conditions: Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Cancer; Suspected Recurrent Renal Clear Cell Carcinoma
• Intervention / Treatment: Drug: 89Zr-Girentuximab

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Cancer Hospital & Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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-TLX250; 89Zr-DFO-girentuximab; TLX250CDx

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Telix International Pty Ltd
• Collaborators: Grand Pharmaceutical (China) Co., Ltd.
• Investigators: Principal Investigator: Zhi Yang, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Actual): November 27, 2023
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: May 14, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: indeterminate renal masses; Suspected Recurrent Renal Clear Cell Carcinoma
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Kidney Neoplasms; Neoplasms, Complex and Mixed; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma, Renal Cell; Carcinoma; Recurrence; Adenocarcinoma, Clear Cell; Adenomyoepithelioma
• Other Study ID Numbers: TLX250CDx-CP-001

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