Actively Recruiting
Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX -Expressing Solid Tumors
Led by Telix Pharmaceuticals (Innovations) Pty Limited · Updated on 2024-05-01
36
Participants Needed
5
Research Sites
184 weeks
Total Duration
On this page
Sponsors
T
Telix Pharmaceuticals (Innovations) Pty Limited
Lead Sponsor
M
Merck KGaA, Darmstadt, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX -Expressing Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed advanced or metastatic solid tumor that progressed after or during standard therapies or patient not eligible/consenting to standard therapies
- At least one measurable lesion on CT/MRI with CAIX positivity shown by 89Zr-TLX250 uptake
- CAIX positivity in at least 75% of total lesion volume with uptake greater than 1.5 times normal liver SUV
- ECOG performance status of 0 or 1
- Adequate organ function during screening
- Life expectancy of at least 6 months
You will not qualify if you...
- Prior treatment with 177Lu-TLX250 or other radioligand therapy or prior CAIX-targeting therapy
- Known allergy to peposertib, girentuximab labeled with zirconium or lutetium, or any study medication components
- Received radionuclide therapy within 10 half-lives before consent
- Chemotherapy, radiation, biological cancer therapy, or investigational therapy within 28 days before first study dose
- More than 2 prior lines of cytotoxic chemotherapy or severe neutropenia/thrombocytopenia during last therapy (may be waived by safety review committee)
- Inability to stop medications that strongly affect CYP450 enzymes or proton-pump inhibitors at least 5 days before treatment
- Receiving therapeutic doses of anticoagulants or platelet aggregation inhibitors (may be waived by safety review committee)
- Having 5 or more bone metastases, bulky pelvic/femoral tumors over 3cm, or spine metastases involving more than 3 vertebrae
- Any severe health condition or uncontrolled infection making study participation unsafe
- Need for other anti-cancer treatments besides study drugs (supportive care allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Macquarie University
North Ryde, New South Wales, Australia
Actively Recruiting
2
Ashford (Icon) Cancer Centre
Adelaide, Australia
Actively Recruiting
3
Princess Alexandra Hospital
Brisbane, Australia
Actively Recruiting
4
Austin Health
Melbourne, Australia
Actively Recruiting
5
GenesisCare Murdoch
Perth, Australia
Actively Recruiting
Research Team
M
MEDICAL DIRECTOR, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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