Evaluation of Safety, Biodistibution and Sensitivity/Specificity of PET/CT Imaging With 89Zr-TLX250 in Subjects With RCC

NCT04496089 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 89Zr-TLX250-004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

89Zr-TLX250 is a carbonic anydrase IX (CAIX)-targeted imaging agent that is under clinical development as a non-invasive diagnostic imaging agent for teh detection of clear cell renal cell carcinoma (ccRCC). The Phase 1 study part of this study is to confirm the safety/tolerability and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) in subjects with suspected renal cell carcinoma (RCC) including clear cell renal cell carcinoma. The Phase 2 component of the study is to to evaluate the sensitivity/specificity of using 89Zr-TLX250 PET/CT images to detect RCC and ccRCC in patients with suspected RCC.

Conditions

Carcinoma, Renal Cell; Clear Cell Renal Cell Carcinoma

Keywords

clear cell renal cell carcinoma; PET/CT imaging; 89Zr-girentuximab; pharmacokinetics; pharmacodynamics; safety; Diagnostic imaging; 89Zr-TLX250

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse events [Safety and Tolerability]

  Incidence of abnormal laboratory test results and abnormal vital signs

  90 days

• Determination of the sensitivity and specificity of 89Zr-TLX250 to detect clear cell renal cell carcinoma

  The sensitivity and specificity of 89Zr-TLX250 to detect renal cell carcinoma will be established by a diagnostic scan after administration of the investigational product followed by surgery of the indeterminate mass. After surgical removal of the kidney mass , diagnostic histology of the mass will be conducted and used as the "standard of truth" comparator.

  90 days

Secondary Outcomes (8)

• Phase 1: Evaluation of the radioactivity distribution and biodistribution/tumor uptake

  0.5, 4, 24, and 72 hours and Day 5 ± 2

• Phase 1: Assessment of tumor uptake

  Day 3-5

• Phase 2: To evaluate positive predictive value (PPV) of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses

  At end of study , on average of 5 months

• Phase 2: To evaluate negative predictive value (NPV) of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses

  At end of study , on average of 5 months

• To evaluate accuracy of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses

  At end of study , on average of 5 months

Study Arms (1)

89Zr-girentuximab

EXPERIMENTAL

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

Diagnostic Test: 89Zr-girentuximab

Interventions

89Zr-girentuximab DIAGNOSTIC_TEST

A single dose of 37 MBq (±10%) is administered. The dose per dose is equivalent to girentuximab 10 mg (±10%).

Also known as: 89Zr-TLX250, 89Zr-DFO-TFP-girentuximab (GTX)

89Zr-girentuximab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase 1:
• Written and voluntarily given informed consent
• Aged ≥20 years at the time of enrollment
• Suspected renal cell carcinoma who have been diagnosed with a renal mass by CT or MRI performed within 90 days before screening
• Sufficient life expectancy to participate in the study
• Consent to practice barrier contraception (condoms) until a minimum of 42 days and 90 days after 89Zr-TLX250 administration in female and male, respectively
• Phase 2 Part
• Written and voluntarily given informed consent
• Aged ≥20 years at the time of enrollment
• Imaging evidence of a single indeterminate renal mass of ≤ 7 cm in largest diameter on CT or MRI within 90 days prior to screening
• Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration
• Sufficient life expectancy to undergo nephrectomy
• Consent to practice barrier contraception (condoms) until a minimum of 42 days and 90 days after 89Zr-TLX250 administration in female and male, respectively

You may not qualify if:

• Commonly applied for Phase 1 part and Phase 2 part
• Those who have hypersensitivity to Girentuximab or DFO
• Patients with metastatic renal tumor
• Patients who need treatment for other active malignancies during the study period
• Patients who have undergone chemotherapy, radiation therapy, or immunotherapy within 4 weeks before the administration of the investigational drug, or have continued adverse events of grade 1 (defined in NCI-CTCAE v5.0) or higher
• Patients scheduled for anticancer drug treatment during the period from administration of investigational drug to image collection
• Patients who have been exposed to mouse or chimeric antibody within the past 5 years
• Patients who have been administered some kind of radionuclide earlier than 10 half-lives of the nuclide.
• Patients with severe, but not fatal disease, for which the principal investigator / investigator has determined that study participation is not appropriate
• Women who are pregnant or breastfeeding. And women with childbearing potential who are not pregnant or breastfeeding but suspected of being pregnant by the blood test at screening and pre-dose (within 24 hours before administration). Pre-dose blood pregnancy test can be replaced with urine test
• Patients who have been administered the drug by any clinical study or clinical trial within 30 days before the scheduled administration of the investigational drug
• Patients who cannot give legally valid consent by himself / herself
• Patients with renal dysfunction whose GFR is 60mL / min / 1.73m2 or less
• Patents who are socially vulnerable (e.g., patients in custody)
• Others who are judged by the principal investigator or investigator to be inappropriate for participation in this trial Applied only to Phase 2 part 15． Patients whose biopsy is more suitable for pathological diagnosis than partial resection or nephrectomy

Sponsors & Collaborators

• Telix Pharmaceuticals (Innovations) Pty Limited: lead

Study Sites (1)

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

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

• Noboru Nakaigawa, MD, PhD

  Yokohama City University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label, safety, pharmacokinetic, diagnostic, prospective, multi-center

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: August 3, 2020
• Study Start: August 1, 2020
• Primary Completion: October 27, 2020
• Study Completion: April 6, 2021
• Last Updated: August 24, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)