Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07197580

Phase 3 Study to Assess Safety and Efficacy of 177Lu-TLX250 in Advanced Relapsed or Recurrent ccRCC

A Phase 3, Randomized, Multi-Center, Open-Label Study to Compare 177Lu-TLX250 (Lutetium (177Lu) Girentuximab Tetraxetan) With the Investigator's Choice of a Single Agent Therapy in Participants With Carbonic Anhydrase 9 (CAIX) Expressing, Advanced Relapsed or Recurrent Clear Cell Renal Cell Carcinoma (ccRCC)

Status
Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Telix Pharmaceuticals (Innovations) Pty Limited · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Multicenter Phase 3 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). Part 2 will compare 177Lu-TLX250 with investigator's choice of monotherapy aligned with Australian standard-of-care.

Detailed description

This is a randomized, open-label, multi-center 3 study evaluating the safety and efficacy of 177Lu-TLX250, a CAIX-targeting radioligand therapy, in adult participants with advanced, relapsed or recurrent clear cell renal cell carcinoma (ccRCC). The study consists of two parts: • Part 1 (Phase 2a - Dose Optimization): Participants will be randomized to receive one of two dosing regimens of 177Lu-TLX250. The objective of Part 1 is to determine the recommended Phase 3 dose (RP3D) for use in Part 2.

Conditions

Interventions

TypeNameDescription
RADIATION177Lu-TLX2503 infusions of 177Lu-TLX250 at 8-week intervals or 6 infusions 177Lu-TLX250 at 4-week intervals

Timeline

Start date
2026-03-25
Primary completion
2027-08-31
Completion
2029-02-28
First posted
2025-09-29
Last updated
2026-04-01

Locations

5 sites across 1 country: Australia

Source: ClinicalTrials.gov record NCT07197580. Inclusion in this directory is not an endorsement.