TLX250-CDx

TLX·Telix Pharmaceuticals·Clear cell renal cell carcinoma (ccRCC) imaging and detection (diagnostic)·Phase 2·NCT06447103·Primary completion: 1 Dec 2029

Plain-language Brief

The trial in plain terms

The disease: Clear cell renal cell carcinoma (ccRCC) is the most common subtype of kidney cancer. Staging and surveillance rely on imaging to detect primary tumours, assess surgical margins, and identify recurrence. Conventional contrast-enhanced computed tomography (CT) is the current standard but has limitations in distinguishing ccRCC from benign renal masses and from other renal tumour subtypes. Accurate non-invasive characterisation of renal masses influences decisions about surgery, active surveillance, and systemic treatment.
What the asset is trying to do: TLX250-CDx is a positron emission tomography (PET) imaging agent based on girentuximab, a monoclonal antibody that binds carbonic anhydrase IX (CAIX), a protein that is highly expressed on the surface of ccRCC tumour cells. The antibody is labelled with the radioactive isotope zirconium-89 (89Zr), allowing a PET scanner to generate images showing where the tracer accumulates in the body. This approach is designed to identify ccRCC specifically by targeting a molecular marker associated with the tumour, rather than relying solely on the anatomical appearance of a mass on CT.
What the trial is measuring, and why it matters: The lead trial (NCT06447103, per ClinicalTrials.gov) compares 89Zr-DFO-girentuximab PET/CT against contrast-enhanced CT for detecting recurrent ccRCC in patients with Stage II-IV disease (per ClinicalTrials.gov NCT06447103). The primary endpoint and detailed secondary endpoints are from the available trial registry data. Imaging accuracy endpoints in diagnostic trials of this type typically include measures of sensitivity and specificity against a pathological or composite reference standard, because those metrics directly reflect how reliably the scan identifies or excludes disease.
Efficacy benchmarks in this setting: In the ZIRCON Phase 3 trial of girentuximab-based PET/CT imaging in patients with indeterminate renal masses, sensitivity of 85.5% and specificity of 87.0% for identifying ccRCC were reported (Shuch et al, NEJM Evidence 2023). Contrast-enhanced CT alone has reported sensitivity for renal mass characterisation in the range of approximately 70-80% in some published series, though results vary by study design and population ( citation). These figures are from different study designs and patient populations and are not statistically comparable to results from NCT06447103, which has not yet reported primary outcome data.
Commercial context

Sources for this brief (5)

ZIRCON trial: Zirconium-89-Girentuximab PET-CT for ccRCC detection · NEJM Evidence · accessed 26 June 2026
NCT06447103 trial registry record · ClinicalTrials.gov · accessed 26 June 2026
Telix Annual General Meeting Presentation 2026 · Telix Pharmaceuticals / ASX · accessed 26 June 2026
Zircaix (89Zr-girentuximab) FDA approval announcement · Telix Pharmaceuticals / ASX · accessed 26 June 2026
Carbonic anhydrase IX expression in renal cell carcinoma: review of the literature · [ TODO: fill in ] · accessed 26 June 2026

Trial Design

Design summary

Phase: Phase 2
Design type: Open-label, multi-centre, imaging comparison study. Single-arm with comparator imaging (89Zr-DFO-girentuximab PET/CT versus contrast-enhanced CT).
Primary endpoint: [ TODO: fill in ] (not specified in available ClinicalTrials.gov registry data for NCT06447103)
Key secondary endpoints: [ TODO: fill in ]
Enrolment target: 91 patients (per ClinicalTrials.gov NCT06447103)
Current enrolment status: Recruiting (per ClinicalTrials.gov NCT06447103; exact number enrolled to date is [ TODO: fill in ])
Sites: [ TODO: fill in ]
Expected readout window: Primary completion is listed as 2029-12-01 (per ClinicalTrials.gov NCT06447103); interim or earlier data readout timing is [ TODO: fill in ].

Asset Track Record

Did TLX deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

20 July 2026commercial milestoneQ2 2026 Revenue US$247M Strong Momentum Pipeline Progresshitsrc
30 June 2026regulatory decisionTLX250-CDx FDA submissionoverdueASX ↗
30 June 2026data readoutPHASE3 data readout — 89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Studyoverduesrc ASX ↗
1 June 2026data readoutPHASE1 data readout — 131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)overduesrc
1 June 2026data readoutPHASE3 data readout — PSMA PET Combined With MRI for the Detection of PCaoverduesrc
13 Apr 2026data readoutResults posted — 89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Studyhitsrc ASX ↗
9 Apr 2026regulatory decisionTLX101-Px (Pixclara, Floretyrosine F 18 / 18F-FET) FDA — FDA Accepts NDA for TLX101-Px (Pixclara)hit · positivesrc
8 Apr 2026data readoutResults posted — 89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Studyhitsrc ASX ↗

Class Catalyst Calendar

What's landed, what's next for TLX250-CDx and peers

TLX250-CDx's own upcoming catalysts alongside class-defining historical readouts and upcoming primary completion dates in the same mechanism classes. Each event moves the broader thesis for TLX250-CDx. Showing past 6 months and next 12 months · 8 later hidden.

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
TLX250-CDxTLX101-Px (Pixclara) FDA PDUFA Decision

Trial design comparison

How TLX250-CDx reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
TLX250-CDx	Telix Pharmaceuticals	Diagnostic Device	Phase 2[ TODO: fill in ]	Open-label, multi-centre, imaging comparison study. Single-arm with comparator imaging (89Zr-DFO-girentuximab PET/CT versus contrast-enhanced CT).	[ TODO: fill in ] (not specified in available ClinicalTrials.gov registry data for NCT06447103)	[ TODO: fill in ]	91 patients (per ClinicalTrials.gov NCT06447103)	91

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

OtherASX peers ›

8 activeexpand ›

T(
89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study
Phase 3
Telix Pharmaceuticals (Innovations) Pty Limited·Recruiting·Primary completion 30 June 2026·NCT06750419
8 sites
PIs: Peng Du, Prof, Xiaolong Qi, Xiaoli Lan, +5

Curated Commentary

Third-party coverage(none curated yet)

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External analyst notes, journalism, and industry commentary cited with attribution.

No third-party coverage curated for TLX250-CDx yet. Broker coverage of Telix Pharmaceuticals is thin; named analyst notes will appear here as they become available. For now, see the company's ASX announcements and the linked sponsor / class sources elsewhere on this page.