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 PharmaceuticalsContacts:
Telix Medical Directorinfo@telixpharma.com
Government Study Link:
NCT05868174 - Click here to see study onClinicalTrials.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