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

NCT05861778 | Completed Phase 1

• 1 other identifier: TLX250CDx-CP-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Clear Cell Renal Cell Carcinoma; Suspected Recurrent Renal Clear Cell Carcinoma; Recurrent Renal Cell Cancer

Keywords

indeterminate renal masses; Suspected Recurrent Renal Clear Cell Carcinoma

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Whole blood radioactivity PK parameters

  6 days

• Radiation dosimetry

  8 days

• 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

Study Arms (1)

89Zr-girentuximab

EXPERIMENTAL

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

Drug: 89Zr-Girentuximab

Interventions

89Zr-Girentuximab DRUG

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.

Also known as: 89Zr-DFO-girentuximab, 89Zr-TLX250, TLX250CDx

89Zr-girentuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Telix Pharmaceuticals (Innovations) Pty Limited: lead
• Grand Pharmaceutical (China) Co., Ltd.: collaborator

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Zhi Yang

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 17, 2023
• Study Start: June 26, 2023
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)