NCT05868174 Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX -Expressing Solid Tumors
| NCT ID | NCT05868174 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Telix Pharmaceuticals (Innovations) Pty Limited |
| Condition | Solid Tumor, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-05-23 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2023-05-23 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Prior 177Lu-TLX250 or other radioligand therapy; or any prior CAIX targeting therapy. * 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. * 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. * 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. * 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.
Contact & Investigator
MEDICAL DIRECTOR, MD
Frequently Asked Questions
Who can join the NCT05868174 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05868174 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05868174 currently recruiting?
Yes, NCT05868174 is actively recruiting participants. Visit ClinicalTrials.gov or contact Telix Pharmaceuticals (Innovations) Pty Limited to inquire about joining.
Where is the NCT05868174 trial being conducted?
This trial is being conducted at North Ryde, Australia, Adelaide, Australia, Brisbane, Australia, Melbourne, Australia and 1 additional location.
Who is sponsoring the NCT05868174 clinical trial?
NCT05868174 is sponsored by Telix Pharmaceuticals (Innovations) Pty Limited. The trial plans to enroll 36 participants.