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

Exclusion Criteria

• •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.
• •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).
• +7 more criteria