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RECRUITING
NCT05868174
PHASE1

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

Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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

COMBINATION_PRODUCT

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