RecruitingPhase 1NCT05868174

Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX -Expressing Solid Tumors

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

Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Enrollment

36 participants

Start Date

May 23, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Solid Tumor, Adult Advanced Renal Cell Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two treatments — a targeted radiation therapy called lutetium-177 (which homes in on a specific protein found on cancer cells) and a drug called peposertib — for people with advanced or metastatic solid tumours that express a protein called CAIX (carbonic anhydrase IX). **You may be eligible if...** - You have an advanced or metastatic solid tumour confirmed by biopsy - Your tumour tests positive for the CAIX protein on imaging - Your cancer has progressed after standard treatments, or standard treatments are not suitable for you - You have at least one measurable tumour on CT or MRI **You may NOT be eligible if...** - Your tumour does not express the CAIX protein - You are not able to tolerate the required scans and procedures - You have certain organ function problems that make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST89Zr-TLX250

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

COMBINATION_PRODUCT177Lu-TLX250 and Peposertib

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.