A Phase 1b Study of 177Lu-TLX250 and Peposertib Combination for CAIX-Expressing Solid Tumors

What this Trial Is About

Researchers are studying the combination of two treatments, 177Lu-TLX250 and peposertib, in patients who have solid tumors that express carbonic anhydrase IX (CAIX). This open-label, single-arm study includes a dose escalation phase to find the best dose combination, followed by a dose expansion phase to further evaluate the treatment. The study focuses on patients with advanced or metastatic solid tumors that have progressed despite standard therapies and includes specific groups such as those with metastatic or non-resectable clear cell renal cell carcinoma (ccRCC). In the first phase, patients receive one of three radioactive doses of 177Lu-TLX250 intravenously on day 1 of each 84-day cycle, combined with peposertib taken orally twice daily from days 4 to 21 of the same cycle. This phase involves small groups to identify the maximum tolerated dose. In the second phase, larger groups receive the recommended dose determined from phase one. Additionally, a diagnostic test involves a single intravenous administration of 89Zr-TLX250 followed by PET/CT or PET/MRI scans to assess tumor uptake. Participants will undergo treatment for up to three 84-day cycles or until disease progression or unacceptable side effects occur. They will have regular safety assessments including laboratory tests, vital signs, ECGs, and monitoring for adverse events over the first 42 days. Disease impact will be evaluated using the ECOG performance scale at several time points. After treatment, follow-up visits occur every three months for up to two years to monitor survival, tumor response, and progression. Blood samples will also be collected to check for immune responses to the treatment.

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