Tests a radioactive drug with peposertib in adults with advanced kidney cancer
Tests 177Lu-TLX250 with peposertib in adults with CAIX-expressing solid tumors.
Plain-language title generated from the registry record
Registry title: Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX -Expressing Solid Tumors
Key facts
- Where
- Adelaide, Brisbane, Melbourne, North Ryde, and Perth, AustraliaSee the 5 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with an advanced solid tumor, including advanced kidney cancer, whose tumor shows the CAIX marker on a special scan. It tests 177Lu-TLX250 together with peposertib.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced or metastatic solid tumor that has progressed on standard treatment and cannot be removed by surgery, or the person cannot or does not want standard treatment. At least one measurable lesion on CT/MRI. ECOG status 0 or 1. Life expectancy of at least 6 months.
- Earlier treatment
- Must not have had 177Lu-TLX250, other radioligand therapy, or any CAIX-targeting therapy. No chemotherapy, definitive radiation, biological cancer therapy or investigational agent/device within 28 days of the first planned dose.
- Biomarker or test result
- CAIX positive on the 89Zr-TLX250 scan, in at least 75% of the total lesion volume.
Main reasons for not taking part
- Prior 177Lu-TLX250, other radioligand therapy or CAIX-targeting therapy
- More than 2 prior lines of cytotoxic chemotherapy, or severe low blood counts during the last line of therapy
- 5 or more bone metastases, or bulky pelvic or femoral tumors, or spine tumor involving more than 3 vertebrae
- Needs therapeutic doses of anticoagulants or platelet aggregation inhibitors
- Active uncontrolled infection or other severe disease
Read by machine on 12 November 2026.
Where in Australia
- Ashford (Icon) Cancer CentreAdelaide, AustraliaContact: Principal InvestigatorTaking people
- Princess Alexandra HospitalBrisbane, AustraliaContact: Principal InvestigatorTaking people
- Austin HealthMelbourne, AustraliaContact: Princiapl InvestigatorTaking people
- Macquarie UniversityNorth Ryde, AustraliaContact: Principal InvestigatorTaking people
- GenesisCare MurdochPerth, AustraliaContact: Principal InvestigatorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Telix Pharmaceuticals (Innovations) Pty Limited
- Trial code
- NCT05868174
- Record updated
- 1 May 2024
- Original description
This is an open label, single-arm, multicentre dose escalation (Part 1) and dose expansion (Part 2) study to evaluate different combinations of 3 radioactive dose levels of 177Lu-TLX250 administered intravenously with 3 different doses of peposertib in patients with CAIX-expressing solid tumors.Read full original descriptionShow less
A Phase 1b Dose Escalation/Expansion Study of the Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX (CAIX)-Expressing Solid Tumors
This is an open label, single-arm, multicentre dose escalation (Part 1) and dose expansion (Part 2) study to evaluate different combinations of 3 radioactive dose levels of 177Lu-TLX250 administered intravenously with 3 different doses of peposertib in patients with CAIX-expressing solid tumors.
Inclusion: Histologically confirmed advanced or metastatic solid tumor that has progressed on or during/after recognized standard of care therapies and are not eligible for resection, or patients that are not eligible or not consenting to recognized standard of care therapies; At least one measurable lesion on CT/MRI according to RECIST 1.1 with corresponding 89Zr-TLX250 uptake (i.e., CAIX positive); CAIX positivity in at least 75% of the total lesion volume (defined as 89Zr- TLX250 uptake with intensity significantly greater than normal liver [i.e., standardized uptake value [SUV]max at least 1.5 times SUV of normal liver]); ECOG status 0 or 1; Have adequate organ function during screening; Must have a life expectancy of at least 6 months.
Exclusion: Prior 177Lu-TLX250 or other radioligand therapy; or any prior CAIX targeting therapy; Administration of any radionuclide within 10 half-lives of the radionuclide prior to signature of the ICF; Patients who have had chemotherapy, definitive radiation, biological cancer therapy, or investigational agent/device within 28 days of first planned dose of study therapy; Patients who had > 2 prior lines of cytotoxic chemotherapy or had Grade 4 neutropenia or Grade 3/Grade 4 thrombocytopenia (both of a duration of at least 48 hours) during the last line of therapy. Note: This criterion may be removed in total or in part by the SRC upon review of the safety data from the initial dose level(s); Patients who cannot discontinue concomitant medications or herbal supplements that are strong inhibitors or strong inducers of cytochrome P450 (CYP) isoenzymes CYP3A4/5, CYP2C9, and CYP2C19. Concomitant use of CYP3A4/5 substrates with a narrow therapeutic index are also excluded; Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol, in the opinion of the investigator; Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study; Requirement of concurrent use of other anti-cancer treatments or agents other than study medications. Supportive care therapies are permitted; Known hypersensitivity to compounds of similar chemical or biologic composition to peposertib, girentuximab radiolabelled by zirconium or lutetium, any excipient in the study medication or any other intravenously administered human proteins/peptides/antibodies; Patients who cannot discontinue concomitant H2-blockers or proton-pump inhibitors (PPIs). Patients may confer with the investigator to determine if such medications can be discontinued. These must be discontinued ≥ 5 days prior to study treatment. Patients do not need to discontinue calcium carbonate; Patients who are receiving therapeutic doses of anticoagulation, including but not limited to low-molecular weight heparin in therapeutic dosing or platelet aggregation inhibitors. Note: This criterion may be removed by the SRC upon review of the safety data from the initial dose level(s); Patients with ≥ 5 bone metastases and/or bulky (> 3cm in diameter) pelvic or femoral tumors, and/or metastases/tumor in the vertebral spine involving > 3 vertebrae.