NCT04496089 (ZIRDAC-JP) is a Phase 1 clinical trial of 89Zr-girentuximab in Carcinoma, Renal Cell, sponsored by Telix Pharmaceuticals (Innovations) Pty Limited.

Who is sponsoring NCT04496089?

NCT04496089 is sponsored by Telix Pharmaceuticals (Innovations) Pty Limited.

What drugs are being tested in NCT04496089?

Interventions in NCT04496089: 89Zr-girentuximab.

What condition does NCT04496089 study?

NCT04496089 studies Carcinoma, Renal Cell, Clear Cell Renal Cell Carcinoma.

Is NCT04496089 still recruiting?

NCT04496089 is currently completed. Last updated 24 August 2021.

Last reviewed 2021-08-24 · How we verify

NCT04496089: ZIRDAC-JP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 24 August 2021

What this trial tests

Phase 1 trial testing 89Zr-girentuximab in Carcinoma, Renal Cell in 6 participants. Completed in 6 April 2021.

Timeline

1 August 2020

Primary endpoint
27 October 2020

6 April 2021

Quick facts

Lead sponsor	Telix Pharmaceuticals (Innovations) Pty Limited
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	health services research
Enrollment	6
Start date	1 August 2020
Primary completion	27 October 2020
Estimated completion	6 April 2021
Sites	1 location across Japan

Drugs / interventions tested

89Zr-girentuximab — full drug profile →

Conditions studied

Carcinoma, Renal Cell — all drugs for Carcinoma, Renal Cell →
Clear Cell Renal Cell Carcinoma — all drugs for Clear Cell Renal Cell Carcinoma →

Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited — full company profile →

Who can join

20 and older, any sex, with Carcinoma, Renal Cell or Clear Cell Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Evaluation of PET/CT imaging with [89Zr]Zr-DFO-girentuximab: a phase 1 clinical study in Japanese patients with renal cell carcinoma (Zirdac-JP).
Nakaigawa N, Hasumi H, Utsunomiya D, Yoshida K, et al · · 2024 · cited 7× · PMID 38864246 · DOI 10.1093/jjco/hyae075
Clinical nuclear medicine applications of zirconium-89 immuno-PET: a comprehensive review from a radiopharmaceutical perspective.
Dubois J, Deshayes E, Kucharczak F, Cadet MM, et al · · 2026 · PMID 42012571 · DOI 10.1186/s41181-025-00418-8

Verify or expand the search:

Other trials of 89Zr-girentuximab

Trials testing the same drug.

NCT03849118 — 89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study · Phase 3 · completed

Other recruiting trials for Carcinoma, Renal Cell

Currently open trials in the same condition.

NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) · Phase 3 · recruiting
NCT07227415 — Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Antica · Phase 1, PHASE2 · recruiting
NCT06222593 — Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With TKIs-resistant · Phase 1, PHASE2 · recruiting
NCT07166445 — Deep Learning for Automated Discrimination Between Stage T1-T2 and T3 Renal Cell Carcinoma on Contrast-Enhanced CT · recruiting
NCT06676527 — Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma · recruiting

Other Telix Pharmaceuticals (Innovations) Pty Limited trials

Trials by the same sponsor.

NCT07197580 — Phase 3 Study to Assess Safety and Efficacy of 177Lu-TLX250 in Advanced Relapsed or Recurrent ccRCC · Phase 3 · recruiting
NCT07197645 — Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain · Phase 1 · recruiting
NCT07238322 — [18F]FET PET for Characterization of Progressive or Recurrent Glioma From Treatment Related Changes · active not recruiting
NCT06655064 — Registry to Evaluate Long-Term Outcomes in Patients Who Undergo 68-Ga-PSMA-11 PET/CT Imaging Evaluations · terminated
NCT06750419 — 89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04496089 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Telix Pharmaceuticals (Innovations) Pty Limited
Last refreshed: 24 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04496089.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing