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ccRCCPhase 3LUTEONNCT07197580

Phase 3 Study to Assess Safety and Efficacy of 177Lu-TLX250 in Advanced Relapsed or Recurrent ccRCC

A Phase 3 study testing 177Lu-TLX250 in people with ccRCC and Renal Cell Carcinoma (Kidney Cancer), run by Telix Pharmaceuticals (Innovations) Pty Limited at 5 sites in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Multicenter Phase 3 study of 177Lu-TLX250 in adult participants with CAIX-expressing advanced, relapsed or recurrent clear cell renal cell carcinoma (ccRCC). Part 1 will evaluate two dosing regimens to determine the recommended Phase 3 dose (RP3D). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
177Lu-TLX250
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
5 sitesAustralia
Study dates
25 Mar 2026to 28 Feb 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • be aged ≥ 18 years.
  • have provided written informed consent, dated and signed by the participant prior to any study-specific procedure;
  • have relapsed or recurrent, locally advanced, or metastatic RCC with histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer Staging Manual (Edge SB et al., 2017), with or without sarcomatoid features;
  • have received at least 2 and no more than 3 prior lines of systemic therapies for locally advanced or metastatic ccRCC including a PD-1/PD-L1 inhibitor (at least 2 administrations) and a VEGF/VEGFR-targeting agent (including TKI or mAb) in sequence or in combination;
  • have had radiographic disease progression occurring during or after the most recent line of therapy or intolerance to most recent line of therapy;
  • have at least one measurable lesion according to RECIST, version 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions;
Show all 21Show fewer
  • be CAIX-positive at Screening defined as having at least 1 lesion with a tumor-lesion CAIX ratio of the maximum standardized uptake value (SUVmax) to liver mean standardized uptake value SUVmean) ≥ 1.5 as determined by BICR of 89Zr-TLX250 PET outcomes;
  • have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1;
  • have recovered from the AEs related to prior lines of therapy or returned to baseline with the exception of Grade 2 neurotoxicity. Ongoing, controlled AEs, such as hypothyroidism or hypertension, are permitted;
  • have adequate organ function, defined as:
  • Bone Marrow:
  • leukocytes ≥ 3,000/µL;
  • absolute neutrophil count ≥ 1500/µL (administration of granulocyte colony stimulating factor is not allowed within 4 weeks prior to the first administration of 177Lu-TLX250;
  • platelets ≥ 100,000/µL (platelet transfusion is not allowed within 4 weeks prior to the first administration of 177Lu-TLX250); and
  • hemoglobin ≥ 9g/dL (red blood cell transfusion is not allowed within 2 weeks prior to the first administration of 177Lu-TLX250).
  • Liver Function:
  • total bilirubin ≤ 1.5 × the upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 × ULN is permitted; and
  • alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5.0 × ULN for participants with liver metastases.
  • Renal Function:
  • creatinine clearance ≥ 40 mL/min as measured by Cockroft-Gault formula or directly calculated by 24h urine;
  • have negative pregnancy test for women of childbearing potential (serum); and

Who cannot join

  • have any of the following:
  • visceral metastatic lesions that are ≥ 1 cm that have a CAIX TLR < 1;
  • lytic bone metastatic lesions with a soft tissue component of at least 1 cm with a TLR < 1; and/or
  • at least one metastatic lymph node lesion with short axis ≥ 2.5 cm with a TLR <1;
  • received prior 177Lu-TLX250 therapy, any other radioligand therapy, or any prior CAIX-targeting therapy;
  • have any known hypersensitivity to compounds of similar chemical or biologic composition to girentuximab, DFO or DOTA linker, zirconium or lutetium, and/or any excipient in the study drug or radiographic contrast-agents;
Show all 31Show fewer
  • has received G-CSF or erythropoietin within 4 weeks prior to laboratory evaluations at Screening;
  • be currently receiving or have received:
  • any radionuclide within 10 half-lives of the radionuclide prior to 89Zr-TLX250 administration;
  • any type of systemic anticancer therapy within 2 weeks before the first administration of 177Lu-TLX250;
  • prior radiotherapy within 2 weeks prior to the first administration of 177Lu-TLX250 (must have recovered from all radiation-related toxicities and not currently require steroid treatment); and/or
  • prior palliative radiation (≤2 weeks of radiotherapy) within 1-week of the first administration of 177Lu-TLX250 for non-central nervous system disease; NOTE: If the investigator feels that the patient is continuing to receive some clinical benefit from standard-of-care (SOC) therapy, the patient may continue SOC therapy up until 2 weeks prior to dosing with 177Lu-TLX250.
  • have known brain metastases, unless these have been treated and stabilized for at least 4 weeks prior to the first administration of 177Lu-TLX250; Note: Participants with a history of brain metastases must have either a head CT with contrast-or brain MRI performed at Screening to document stable disease prior to the first administration of 177LuTLX250.
  • Have experienced any major trauma including major surgery (such as abdominal/ cardiac/thoracic surgery) within 3 weeks of administration of the first administration of 177LuTLX250;
  • be pregnant or intend to become pregnant, breastfeed, or conceive a child during the study period and for at least 42 days after last administration of 89Zr-TLX250 or 6 months after last administration of 177Lu-TLX250, depending on which study drug is administered last to the respective participant;
  • Note: Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies (see Appendix 10.4).
  • be planning to breastfeed during the study period and for 28 days after last administration of 89ZrTLX250 or 75 days after last administration of 177Lu-TLX250, depending on which study drug is administered last to the respective participant;
  • have active and uncontrolled infections requiring systemic therapy or other severe concurrent disease, which, in the opinion of the investigator, would place the participant at undue risk or interfere with the study;
  • have a history of concurrent malignancy with a life expectancy of ≤ 2 years or requirement of systemic anti-cancer therapy or requirement of local therapy that would confound study results; however; participants with the following malignancies can be enrolled into the study:
  • basal cell or squamous cell carcinoma of the skin;
  • carcinoma in situ of the cervix, breast or bladder; and/or
  • incidental histologic finding of prostate cancer;
  • have a serious, non-healing wound, ulcer, or bone fracture;
  • be unable to stay in the scanner bed with the arms resting out of the thoracic and abdominal fields (i.e., arms alongside the body or raised arm position) for the duration of the scan;
  • have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1 (except for laboratory parameters specified above, Grade 2 alopecia, and/or stable Grade 2 sensory neuropathy, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0;
  • have inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, etc.);
  • have a life expectancy shorter than 3 months;
  • have bleeding or thrombotic disorders or subjects at risk for severe hemorrhage;
  • have experienced any clinically significant bleeding, including hemoptysis or tumor bleeding within 2 weeks prior to the first administration of 177Lu-TLX250;
  • has evidence of a serious active or sub-clinical infection or angina pectoris (New York Heart Association [NYHA] Class III or IV), significantly prolonged QT interval or other serious illness(es) involving the cardiac, respiratory, central nervous system, renal, hepatic or hematological organ systems, that might impair the ability to complete this study or could interfere with determination of causality of any adverse effects experienced in this study, or which require treatment that could interact with study treatment; or
  • have any medical or other condition that in the opinion of the investigator(s) would preclude the subject's participation in a clinical study.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Prson Gautam, PhD contact

19196508158

prson.gautam@telixpharma.com

Lily Nahidi, PhD contact

lily.nahidi@telixpharma.com

5 sites in 1 country

Australia5 sites, 5 recruiting

  • Austin Health

    Heidelberg, Victoria, 3084

    Tina Chen, +61 3 9496 5748, Tina.CHEN@austin.org.au

    Not yet recruiting

  • Melbourne Theranostic Innovation Centre (MTIC)

    Melbourne N., Victoria, 3051

    Christopher Marinakis, +61 3 9453 5804, cmarinakis@mtic.net.au

    Not yet recruiting

  • GenesisCare, Fiona Stanley Hospital (Murdoch)

    Murdoch, Washington, 6150

    Wilna Van Der Watt, +61 8 9366 1533, Wilna.VanDerWatt@genesiscare.com

    Recruiting

  • Westmead Hospital

    Sydney, New South Wales, 2145

    Meenal Rai, 02 8890 8935, meenal.rai@health.nsw.gov.au

    Not yet recruiting

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

    Carly Leighton, 02 4222 5085, carly.leighton@health.nsw.gov.au

    Not yet recruiting

Other trials in Australia

About this study

Official title: A Phase 3, Randomized, Multi-Center, Open-Label Study to Compare 177Lu-TLX250 (Lutetium (177Lu) Girentuximab Tetraxetan) With the Investigator's Choice of a Single Agent Therapy in Participants With Carbonic Anhydrase 9 (CAIX) Expressing, Advanced Relapsed or Recurrent Clear Cell Renal Cell Carcinoma (ccRCC)

Multicenter Phase 3 study of 177Lu-TLX250 in adult participants with CAIX-expressing advanced, relapsed or recurrent clear cell renal cell carcinoma (ccRCC). Part 1 will evaluate two dosing regimens to determine the recommended Phase 3 dose (RP3D). Part 2 will compare 177Lu-TLX250 with investigator's choice of monotherapy aligned with Australian standard-of-care.

Read the detailed description

This is a randomized, open-label, multi-center 3 study evaluating the safety and efficacy of 177Lu-TLX250, a CAIX-targeting radioligand therapy, in adult participants with advanced, relapsed or recurrent clear cell renal cell carcinoma (ccRCC).

The study consists of two parts:

  • Part 1 (Phase 2a - Dose Optimization): Participants will be randomized to receive one of two dosing regimens of 177Lu-TLX250.

The objective of Part 1 is to determine the recommended Phase 3 dose (RP3D) for use in Part 2.

Being tested
177Lu-TLX250
Keywords
Carbonic anhydrase 9, Clear Cell Renal Cell Cancer, Kidney Cancer, ccRCC, CA9, CA-9, CAIX, Girentuximab, CA9 target therapy, Positron-Emission Tomography, Radiation Therapy, Radiopharmaceuticals, Targeted Radiation
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-TLX250Radiation

    Also called TLX250-Tx, 177Lu girentuximab tetraxetan

    3 infusions of 177Lu-TLX250 at 8-week intervals or 6 infusions 177Lu-TLX250 at 4-week intervals

Study groups in NCT07197580
Study groupRoleWhat they receive
1887MBq 177Lu-girentuximab tetraxetanExperimental3 infusions of 1887 MBq 177Lu-TLX250 at 8-week intervals or 6 infusions of 1258 MBq 177Lu-TLX250 at 4-week intervals (fractionation of 3 doses of 2516 MBq)
Receives: Radiation: 177Lu-TLX250
1258 MBq 177Lu-girentuximab tetraxetanExperimental6 infusions of 1258 MBq 177Lu-TLX250 at 4-week intervals
Receives: Radiation: 177Lu-TLX250

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Optimization -safety and tolerability

    Part 1 of the study is being done to identify the best dose to use for Part 2 of the study.

    Assessing adverse events of special interest (AESIs), incidence and severity of treatment-emergent adverse events (TEAEs) and frequency, severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V5.0, seriousness, and relationship of study treatment will be assessed. Laboratory abnormalities will be assessed according to the NCI CTCAE V5.0.

    Measured: Through study completion, an average of 1.5 years

  2. Efficacy- median mPFS

    Primary objective for Part 2 of the study and secondary objective for Part 1. Monitoring disease progression according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).

    Measured: Through study completion, an average of 2 years

Secondary outcomes (29)

  1. Monitoring OS (Overall Survival)

    Time from the date of randomization to death from any cause

    Measured: Through study completion, an average of 2 years

  2. Monitoring ORR (Objective Response Rate)

    Proportion of participants achieving confirmed objective response rate (ORR), i.e., complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) as assessed by a blinded independent central review (BICR)

    Measured: Through study completion, an average of 2 years

  3. Monitoring DoR (Duration of Response)

    Time from the first documentation of objective response, i.e., complete response (CR) or partial response (PR) to the first documentation of disease progression or death due to any cause as assessed by blinded independent central review (BICR)

    Measured: Through study completion, an average of 2 years

  4. Monitoring DCR (Disease control Rate)

    The proportion of participants achieving confirmed objective response, i.e., complete response (CR), partial response (PR), or stable disease (SD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR)

    Measured: Through study completion, an average of 2 years

  5. Evaluate blood radioactive PK parameter- Cmax (maximum plasma concentration)

    Gamma-counting blood radioactivity will be used to derive this pharmacokinetics parameter

    Measured: Treatment period (4 months)

  6. Evaluate blood radioactive PK parameter- AUCinf (area under blood concentration time curve from zero to infinity)

    Gamma-counting blood radioactivity will be used to derive this pharmacokinetics parameter.

    Measured: During Treatment (4 months)

  7. Evaluate blood radioactive PK parameter- t1/2 (Terminal half-life)

    Gamma-counting blood radioactivity will be used to derive this pharmacokinetics parameter.

    Measured: During Treatment (4 months)

  8. Evaluate blood radioactive PK parameter- CL (Clearance)

    Gamma-counting blood radioactivity will be used to derive this pharmacokinetics parameter.

    Measured: During Treatment (4 months)

  9. Tumor and Organ-specific 177Lu-TLX250 absorbed radiation values

    Images-radiation values for tumor and lesions will be measured and analyzed after first and second administration of 177Lu-TLX250.

    Measured: During Treatment (4 months)

  10. TAC for tumor and organ

    Time Activity Curves (TAC) will be used to derive time integrated activity parameters in tumor and organ

    Measured: During Treatment (4 months)

  11. Tumor- and organ-specific 177Lu-TLX250 residence time

    Residence time of 177Lu-TLX250 in tumor and organs will be derived and interpreted

    Measured: During Treatment (4 months)

  12. Identification of dose-limiting organ(s)

    Absorbed dose will be compared to maximal dosimetry threshold for each organ to evaluated the dose limiting organ

    Measured: During Treatment (4 months)

  13. Characterize health utility as measured using the European Quality of Life 5 Dimensions 5 Level Version (EuroQoL EQ-5D-5L)

    Health utility scores from the European Quality of Life 5 Dimensions 5 Level Version (EuroQoL EQ-5D-5L) questionnaire

    Measured: Through study completion, an average of 2 years

  14. Change from Baseline in EORTC QLQ-C30 Physical Functioning

    Assessed using the EORTC QLQ-C30 questionnaire to evaluate physical functioning.

    Measured: Through study completion, an average of 2 years

  15. Change from Baseline in EORTC QLQ-C30 Global Health Status/HRQoL

    Assessed using the EORTC QLQ-C30 questionnaire to evaluate overall health-related quality of life.

    Measured: Through study completion, an average of 2 years

  16. Change from Baseline in FKSI-DRS Subscale

    Assessed using the FKSI-DRS (Functional Assessment of Cancer Therapy - Kidney Symptom Index) to evaluate disease-related symptoms.

    Measured: Through study completion, an average of 2 years

  17. Incidence and Severity of AESIs and TEAEs

    Adverse events will be assessed and graded per NCI-CTCAE v5.0 criteria.

    Measured: Through study completion, an average of 2 years

  18. Dosing Delays Due to 177Lu-TLX250-Related TEAEs

    Number of dosing delays attributed to TEAEs related to 177Lu-TLX250.

    Measured: Through study completion, an average of 2 years

  19. Activity Level Reductions Due to 177Lu-TLX250-Related TEAEs

    Number of participants with reduced activity levels due to TEAEs related to 177Lu-TLX250.

    Measured: Through study completion, an average of 2 years

  20. Evaluation of Immunogenicity (HACA)

    Incidence of HACA positivity, overall per treatment group, and per visit (to track incidence over time)

    Measured: Through study completion, an average of 2 years

  21. Evaluation of HACA on PK/Biodistribution

    Evaluate any correlation of incidence of HACA positivity to changes in PK/Biodistribution per treatment group

    Measured: Through study completion, an average of 2 years

  22. Evaluation of HACA on efficacy/safety

    Evaluate any correlation of incidence of HACA positivity to changes in efficacy/safety end points per treatment group

    Measured: Through study completion, an average of 2 years

  23. Characterization of HACA neutralizing activity

    For confirmed positive HACA samples, incidence of nAb positivity, overall per treatment group, and per visit (to track incidence over time), as applicable

    Measured: Through study completion, an average of 2 years

  24. Evaluation of nAb on PK/Biodistribution

    Evaluate any correlation of incidence of nAb positivity to changes in PK/Biodistribution per treatment group

    Measured: Through study completion, an average of 2 years

  25. Evaluation of nAB on efficacy/safety

    Evaluate any correlation of incidence of nAb positivity to changes in efficacy/safety end points per treatment group

    Measured: Through study completion, an average of 2 years

  26. Evaluate Radiation Exposure-Response parameter- normalized absorbed dose to individual organs (mGy/MBq)

    Evaluate relationship between normalized absorbed dose to individual organs with DCR, ORR and incidence and severity of AESI

    Measured: Through study completion, an average of 2 years

  27. Evaluate Radiation Exposure-Response parameter- AUC

    Evaluate relationship between AUC to individual organs with DCR, ORR and incidence and severity of AESI.

    Measured: Through study completion, an average of 2 years

  28. Evaluate Radiation Exposure-Response parameter- Cmax

    Evaluate relationship between Cmax to individual organs with DCR, ORR and incidence and severity of AESI.

    Measured: Through study completion, an average of 2 years

  29. Evaluate Radiation Exposure-Response parameter- normalized absorbed dose to tumors (mGy/MBq)

    Evaluate relationship between normalized absorbed dose to tumor with DCR, ORR and incidence and severity of AESI.

    Measured: Through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2025
  2. Study start25 Mar 2026
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07197580
Sponsor's protocol ID
177Lu-TLX250-302
Acronym
LUTEON
Status last verified
Mar 2026
First submitted
18 Aug 2025
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We have opted not to share individual participant data due to concerns regarding participant privacy and the absence of explicit consent for data sharing in the original trial protocol.

Publications

  • Muselaers CH, Boers-Sonderen MJ, van Oostenbrugge TJ, Boerman OC, Desar IM, Stillebroer AB, Mulder SF, van Herpen CM, Langenhuijsen JF, Oosterwijk E, Oyen WJ, Mulders PF. Phase 2 Study of Lutetium 177-Labeled Anti-Carbonic Anhydrase IX Monoclonal Antibody Girentuximab in Patients with Advanced Renal Cell Carcinoma. Eur Urol. 2016 May;69(5):767-70. doi: 10.1016/j.eururo.2015.11.033. Epub 2015 Dec 23.

    PubMed 26706103

  • Stillebroer AB, Boerman OC, Desar IM, Boers-Sonderen MJ, van Herpen CM, Langenhuijsen JF, Smith-Jones PM, Oosterwijk E, Oyen WJ, Mulders PF. Phase 1 radioimmunotherapy study with lutetium 177-labeled anti-carbonic anhydrase IX monoclonal antibody girentuximab in patients with advanced renal cell carcinoma. Eur Urol. 2013 Sep;64(3):478-85. doi: 10.1016/j.eururo.2012.08.024. Epub 2012 Aug 21.

    PubMed 22980441

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 177Lu-TLX250 in people with ccRCC and Renal Cell Carcinoma (Kidney Cancer), run by Telix Pharmaceuticals (Innovations) Pty Limited at 5 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Prson Gautam, PhD (19196508158, prson.gautam@telixpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Optimization -safety and tolerability (time frame: Through study completion, an average of 1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07197580, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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