Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX -Expressing Solid Tumors
Trial Parameters
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 radiola