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

Description:

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)

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

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