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

NCT07197580 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • ccRCC
  • Renal Cell Carcinoma (Kidney Cancer)
  • Renal Cell Carcinoma (RCC)
  • Renal Cell Cancer Metastatic
  • Renal Cell Cancer, Recurrent
  • Clear Cell Renal Cell Cancer (ccRCC)

Interventions

RADIATION

177Lu-TLX250

3 infusions of 177Lu-TLX250 at 8-week intervals or 6 infusions 177Lu-TLX250 at 4-week intervals

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Telix Pharmaceuticals (Innovations) Pty Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-25
Primary Completion
2027-08-31
Completion
2029-02-28

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07197580 on ClinicalTrials.gov