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177Lu-TLX250 for Kidney Cancer

(LUTEON ATLAS Trial)

Not yet recruiting at 7 trial locations
PG
Overseen ByPrson Gautam, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Multicenter Phase 2A study of 177Lu-TLX250 in adult participants with CAIX-expressing advanced, relapsed or recurrent clear cell renal cell carcinoma (ccRCC). Part 1 will evaluate two dosing regimens to determine the recommended Phase 3 dose (RP3D).

Are You a Good Fit for This Trial?

This trial is for adults with advanced clear cell kidney cancer (ccRCC) that has come back or hasn't responded to treatment, and whose tumors show CAIX protein. Participants must be generally healthy enough for the study.

Inclusion Criteria

Have provided written informed consent prior to any study-specific procedure
I have had 2 or 3 treatments for advanced kidney cancer, including PD-1/PD-L1 and VEGF drugs.
Women of childbearing potential must have negative serum pregnancy test during screening and prior to IMP dose, not be breastfeeding, and agree to use highly effective contraception during treatment and for 6 months after last IMP dose
See 10 more

Exclusion Criteria

I have received G-CSF or erythropoietin in the last 4 weeks.
I do not have allergies to the study drugs or contrast agents.
I have metastatic tumors in my organs that are at least 1 cm and meet the CAIX test criteria.
See 22 more

What Are the Treatments Tested in This Trial?

Interventions

  • 177Lu-TLX250

Trial Overview

The study is testing two different dosing schedules of a new targeted radiation therapy called 177Lu-TLX250 in people with advanced ccRCC. The goal is to find out which dose works best and is safest.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: 1887MBq 177Lu-girentuximab tetraxetanExperimental Treatment1 Intervention
Group II: 1258 MBq 177Lu-girentuximab tetraxetanExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Telix Pharmaceuticals (Innovations) Pty Limited

Lead Sponsor

Trials
23
Recruited
2,400+

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