Clinical trial NCT05861778: Evaluation of 89Zr-TLX250 PET/CT in Chinese Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: Telix Pharmaceuticals (Innovations) Pty Limited
Sponsor class: INDUSTRY
Collaborators: name: Grand Pharmaceutical (China) Co., Ltd.
First posted: 2023-05-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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).

Primary outcomes:
measure: Safety parameter Physical Examination
timeFrame: 9 days
measure: Safety parameter Vital Signs
timeFrame: 9 days
measure: Safety parameter Laboratory examinations
timeFrame: 9 days
measure: Safety parameter concomitant medications
timeFrame: 9 days
measure: Safety parameter ECG
timeFrame: 9 days
Secondary outcomes:
measure: Whole blood radioactivity PK parameters
timeFrame: 6 days
measure: Radiation dosimetry
timeFrame: 8 days
measure: Tumour dosimetry
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Zhi Yang
role: PRINCIPAL_INVESTIGATOR
References: