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Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX -Expressing Solid Tumors
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.
Study details:
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:. * Cohort A: 40 patients with metastatic or non-resectable ccRCC.
* 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-05-23
Primary completion: 2024-12-01
Study completion finish: 2026-12-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05868174
Intervention or treatment
DIAGNOSTIC_TEST: 89Zr-TLX250
COMBINATION_PRODUCT: 177Lu-TLX250 and Peposertib
Conditions
- • Solid Tumor, Adult
- • Advanced Solid Tumor
- • Advanced Renal Cell Carcinoma
Find a site
Closest Location:
Macquarie University
Research sites nearby
Select from list below to view details:
Macquarie University
North Ryde, New South Wales, Australia
Ashford (Icon) Cancer Centre
Adelaide, Not Specified, Australia
Princess Alexandra Hospital
Brisbane, Not Specified, Australia
Austin Health
Melbourne, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: 89Zr-TLX250, 177Lu-TLX250 and Peposertib
| DIAGNOSTIC_TEST: 89Zr-TLX250
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Safety parameter Dose Limited Toxicity (DLT) | Dose level toxicity evaluation using Partial Ordering Bayesian Logistic Regression Model Method (PO-BLRM) | 42 days |
Safety parameter Laboratory Examinations | Frequency of occurrence and severity of abnormal findings in safety investigations regarding Laboratory examinations | 42 days |
Safety parameter Vital signs | Frequency of occurrence and severity of abnormal findings in safety investigations regarding the vital signs | 42 days |
Safety parameter ECG | Frequency of occurrence and severity of abnormal findings in the 12-lead ECG (ECG QT interval) | 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 | 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. | Screening/Baseline, Day1, Day 29, D57 and End of Treatment |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Overall Survival (OS) | Overall Survival (OS), determined from enrollment , until death from any cause | 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 \[tumor response by RECIST 1.1 and overall radiological response by RECIST 1.1\]) | 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) | 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. | 84 days |
Frequently Asked Questions
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