Study 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

Study Details

Description:

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.

Sponsor:

Telix Pharmaceuticals

Contacts:

Telix Medical Director

info@telixpharma.com

Government Study Link:

NCT05868174 - Click here to see study on

ClinicalTrials.gov

Inclusion

CAIX positivity in at least 75% of total lesion volume
At least 1 measurable lesion on CT/MRI according to RESIST 1.1 with corresponding TLX250-89Zr uptake
Histologically confirmed advanced or metastatic solid tumor that has progressed on or during/after recognized SoC

Exclusion

Prior 177Lu-TLX250 or other radioligand therapy; or any prior CAIX-targeting therapy
>2 prior lines of cytotoxic chemotherapy or had Grade 4 neutropenia or Grade 3/4 throbocytopenia
Cannot discontinue concomitant H2-blockers, PPIs, or medications that are inhibitors or inducers of CYP isoenzymes
>=5 bone metastases or bulky (>3cm diameter) pelvic or femoral tumors or tumor in the spine involving >3 vertebrae
Administration of any radionuclide within 10 half-lives of the radionuclide

Patient Education

Patient Education Not Yet Provided

Publications

Publications Not Yet Provided

Locations

Australia

Austin Health

Victoria, Australia

GenesisCare Murdoch

Perth, Western Australia, Australia

Ashford (Icon) Cancer Centre

Adelaide, South Australia, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Macquarie University

New South Wales, Australia

Contact XCancer: 402-991-8468