Clinical Trial · NCT05868174

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

Overview

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

Phase

Phase 1

Contacts

Telix Medical Director

info@telixpharma.com

ClinicalTrials.gov

NCT05868174

Drug / Compound

Isotope(s):

Target(s):

Eligibility

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

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Locations

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