Brief Summary
This is an open label, single-arm, multicentre dosethe amount of medication taken 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.
Intervention / Treatment
- Diagnostic Test: 89Zr-TLX250
- Combination Product: 177Lu-TLX250 and Peposertib
Inclusion Criteria:
- Histologically confirmed advancedat a late stage, far along or metastatic solid tumor that has progressed on or during/after recognized standard of care therapies and are not eligible for resectionsurgical removal of tissue or part/all of an organ, 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 screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening
- Must have a life expectancy of at least 6 months.