A Phase 1 interventional study of 89Zr-TLX250 and 177Lu-TLX250 and Peposertib in Solid Tumor, Adult, Advanced Solid Tumor and Advanced Renal Cell Carcinoma, sponsored by Telix Pharmaceuticals (Innovations) Pty Limited. Recruiting at 5 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by Telix Pharmaceuticals (Innovations) Pty Limited · Phase 1, Interventional, and Treatment
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:
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 36 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Telix Pharmaceuticals (Innovations) Pty Limited is the lead sponsor of 20 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Diagnostic test: A single IV administration of 37 Megabecquerel (+/- 10%) 89Zr-DFO-girentuximab, containing a mass dose of 10 mg of girentuximab, followed by a diagnostic scan Treatment test: A single IV administration that could be 1887 - 2516 or 3145 Megabecquerel (+/- 10%) 177Lu-DOTA-girentuximab,containing a mass dose of 10 mg of girentuximab, on Day 1 of each 84-day cycle and p.o. administration of that could be 100-150 or 200 mg Peposertib BID on days 4-21 of each 84-day cycle.
Diagnostic Test: 89Zr-TLX250 · Combination Product: 177Lu-TLX250 and Peposertib
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
Also known as: 89Zr-DFO-girentuximab
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.
Also known as: 177Lu-DOTA-girentuximab
Safety parameter Dose Limited Toxicity (DLT)
Dose level toxicity evaluation using Partial Ordering Bayesian Logistic Regression Model Method (PO-BLRM)
Time frame: 42 days
Safety parameter Laboratory Examinations
Frequency of occurrence and severity of abnormal findings in safety investigations regarding Laboratory examinations
Time frame: 42 days
Safety parameter Vital signs
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the vital signs
Time frame: 42 days
Safety parameter ECG
Frequency of occurrence and severity of abnormal findings in the 12-lead ECG (ECG QT interval)
Time frame: 42 days
Safety parameter Adverse Events and Treatment-Related Adverse Events
Assessment of AEs graded by the Common Terminology Criteria for Adverse Events (CTCAE) Criteria, Version 5.0
Time frame: 42 days
Disease impact causing changes in Eastern Cooperative Oncology Group (ECOG) Performance scale.
Quality of life ( in terms of their ability to care for themself, daily activity, and physical ability (walking, working) is to be evaluated using the ECOG Performance Scale.
Time frame: Screening/Baseline, Day1, Day 29, D57 and End of Treatment
Overall Survival (OS)
Overall Survival (OS), determined from enrollment , until death from any cause
Time frame: Every 3 months ± 2 weeks for 24 months after the last 177Lu-TLX250 administration
Tumor objective response rate (ORR)
Tumor response in terms of objective response rate (ORR) (solid tumor tissue response and overall radiological response \[tumor response by RECIST 1.1 and overall radiological response by RECIST 1.1\])
Time frame: Every 3 months ± 2 weeks for 12 months after the last 177Lu-TLX250 administration
Progression-free survival (PFS)
Progression free survival (PFS) defined as the time from enrollment to disease progression confirmed by radiology, clinical progression or death (whichever comes first)
Time frame: Every 3 months ± 2 weeks for 12 months after the last 177Lu-TLX250 administration
Immunogenicity by formation of ADA(HACA) in blood
This outcome will be measured by analyzing the incidence of ADA(HACA) formation in blood on day 1, day 22, Day 43, Day 57 of each cycle (each cycle is 84 days) and at the end of treatment visit.
Time frame: 84 days
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Telix Pharmaceuticals (Innovations) Pty Limited