TheranosticTrials.org

Clinical Trial · NCT07615348

CD70-Targeted Immuno-PET/CT-Directed Free of Therapy Used for mccRCC Patients With IMDC Favorable or Intermediate Risk

Overview

The purpose of this study is to evaluate the safety and feasibility of a treatment holiday strategy directed by CD70-targeted immuno-PET/CT in patients with metastatic clear cell renal cell carcinoma (mccRCC). Specifically, the study aims to assess whether patients who achieve both anatomical disease control and metabolic response after 12 months of first-line PD-1/PD-L1 ICI + VEGFR-TKI combination therapy can safely pause their treatment, improve quality of life without compromising therapeutic efficacy.

Sponsor

Central Hospital, Nancy, France

Phase

Phase 2

Contacts

Le Qu, Ph.D. (CONTACT)

septsoul@hotmail.com

+86 15720625951

Le Qu, Ph.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07615348

Drug / Compound

CD70-targeted immuno-PET agent (single-domain antibody)

Isotope(s):
Target(s):
  • CD70
Ligand Class: Small Proteins and Antibody Fragments

Eligibility

Inclusion

  • Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC (American Joint Committee on Cancer \[AJCC\] Stage IV)
  • STEP0: At Treatment Initiation
  • Male or female subjects aged ≥ 18 years
  • Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype
  • Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria

Exclusion

  • STEP0: At Treatment Initiation
  • Inadequate organ and bone marrow function
  • Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria
  • Prior systemic therapy for advanced RCC
  • Karnofsky Performance Status (KPS) \<70%