Actively Recruiting
Phase 3 Study to Assess Safety and Efficacy of 177Lu-TLX250 in Advanced Relapsed or Recurrent ccRCC
Led by Telix Pharmaceuticals (Innovations) Pty Limited · Updated on 2026-04-01
40
Participants Needed
5
Research Sites
153 weeks
Total Duration
On this page
Sponsors
T
Telix Pharmaceuticals (Innovations) Pty Limited
Lead Sponsor
M
Medpace, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 3 Study to Assess Safety and Efficacy of 177Lu-TLX250 in Advanced Relapsed or Recurrent ccRCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Provided written informed consent before any study procedure
- Diagnosed with relapsed, recurrent, locally advanced, or metastatic clear cell renal cell carcinoma confirmed by pathology
- Received 2 to 3 prior systemic therapies including a PD-1/PD-L1 inhibitor and a VEGF/VEGFR-targeting agent
- Experienced disease progression or intolerance during or after the last therapy
- Have at least one measurable tumor lesion according to RECIST 1.1 criteria
- Positive for CAIX expression on PET scan with a tumor-lesion CAIX ratio of at least 1.5
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Recovered from side effects of prior therapies except stable Grade 2 neurotoxicity
- Adequate bone marrow, liver, and kidney function based on specified laboratory values
- Negative pregnancy test for women of childbearing potential
You will not qualify if you...
- Visceral metastatic lesions 1 cm or larger with CAIX tumor-lesion ratio less than 1
- Lytic bone metastases with soft tissue component 1 cm or larger with CAIX ratio less than 1
- Metastatic lymph node lesion with short axis 2.5 cm or larger with CAIX ratio less than 1
- Prior treatment with 177Lu-TLX250, other radioligand therapy, or CAIX-targeting therapy
- Known allergy to girentuximab, DFO, DOTA linker, zirconium, lutetium, or related products
- Received granulocyte colony stimulating factor or erythropoietin within 4 weeks before screening
- Recent radionuclide, systemic anticancer therapy, or radiotherapy within specified timeframes
- Untreated or unstable brain metastases
- Major trauma or surgery within 3 weeks before first treatment
- Pregnant, breastfeeding, or planning pregnancy during and shortly after the study
- Active uncontrolled infections or severe concurrent diseases
- Other cancers with life expectancy less than 2 years except certain skin or in situ cancers
- Serious non-healing wounds, ulcers, or bone fractures
- Unable to remain still during scans
- Unresolved significant toxic effects from prior cancer treatments except specified conditions
- Inflammatory bowel disease
- Life expectancy under 3 months
- Bleeding or thrombotic disorders or recent significant bleeding
- Serious active infections or heart, lung, brain, kidney, liver, or blood diseases that could interfere with the study
- Any medical condition that would prevent safe participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Not Yet Recruiting
2
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
Not Yet Recruiting
3
Austin Health
Heidelberg, Victoria, Australia, 3084
Not Yet Recruiting
4
Melbourne Theranostic Innovation Centre (MTIC)
Melbourne N., Victoria, Australia, 3051
Not Yet Recruiting
5
GenesisCare, Fiona Stanley Hospital (Murdoch)
Murdoch, Washington, Australia, 6150
Actively Recruiting
Research Team
P
Prson Gautam, PhD
CONTACT
L
Lily Nahidi, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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