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Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX -Expressing Solid Tumors
Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited
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.
Official title: A Phase 1b Dose Escalation/Expansion Study of the Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX (CAIX)-Expressing Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2023-05-23
Completion Date
2026-12
Last Updated
2024-05-01
Healthy Volunteers
No
Interventions
89Zr-TLX250
Single IV administration followed by 89Zr-DFO-girentuximab PET/CT (or PET/MRI) scan at screening and approximately 8-10 weeks (±1 week) after Cycle 3 Day 1, as well as at the end of treatment visit (if feasible). The PET/CT should be obtained within 4-7 days after 89Zr-TLX250 administration
177Lu-TLX250 and Peposertib
Dose escalation and de-escalation for the determination of the Maximum tolerated combination/ Recommended phase 2 dose. All subjects will receive 177Lu-TLX250 intravenously on day 1 and Peposertib BID on days 4-21 of each 84-day cycle.
Locations (5)
Macquarie University
North Ryde, New South Wales, Australia
Ashford (Icon) Cancer Centre
Adelaide, Australia
Princess Alexandra Hospital
Brisbane, Australia
Austin Health
Melbourne, Australia
GenesisCare Murdoch
Perth, Australia