Trial 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.
Part 1 (dose escalation) will evaluate the combination of 3 different activities of 177Lu-TLX250 and 3 different dose levels of peposertib.
Patients with CAIX positive solid tumors will be enrolled in a given dose/activity level in Cohorts of approximately 2-6 patients.
Treatment cycles will have a fixed length of 84 days. Patients will be treated during 3 cycles, or until clinically significant progression or unacceptable toxicity.
Part 2 (dose expansion) patients will be enrolled in 2 Cohorts:
|— a) Cohort A: 40 patients with metastatic or non-resectable ccRCC
|— b) Cohort B: 20 patients with CAIX-positive solid tumors (excluding RCC).
Patients will be treated at the Recommended phase 2 dose of 177Lu-TLX250 in combination with peposertib at the dosing schedule of the selected Recommended phase 2 dose.
Trial details
Short title
STARSTRUCK / 177Lu-TLX250-001
Diagnosis
Advanced solid tumours
Type of treatment
Medical Oncology
Phase
Ib
Locations
Who can participate
Clinical trials can have restrictive criteria of who can and can’t participate, talk to your healthcare provider if you are interested in this clinical trial.