Study Title

Safety, Tolerability, Imaging Characteristics, and Efficacy of 68Ga-NYM096/177Lu-NYM096 in the Treatment of Patients with Metastatic Clear Cell Renal Cell Carcinoma

Study Details

Description:

This is a single-center, phase I study. Patients with metastatic clear cell renal cell carcinoma will be recruited in this study to (Phase A) evaluate using 68Ga-NYM096 PET/CT and to (Phase B) treat with 177Lu-NYM096. The study will be conducted in two phases. The purpose is Phase A: to evaluate the safety, tolerability, and imaging characteristics of 68Ga-NYM096 Phase B: to evaluate the safety, tolerability, and recommended phase 2 dose of 177Lu-NYM096

Sponsor:

Peking Union Medical College Hospital

Government Study Link:

NCT06649682 - Click here to see study on

ClinicalTrials.gov

Drug Details

68Ga-NYM096
Isotope(s):
    GALLIUM-68
    Radioisotope: Ga-68
    Theranostic Role: PET Imaging
    T1/2 (Half-Life): 68 minutes
    Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
    Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
    Range: N/A
    Decay Daughters: Zn68 (Stable)
    Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
  • GALLIUM-68
Target(s):
  • CAIX
Ligand: Small Molecules
177Lu-NYM096
Isotope(s):
    LUTETIUM-177
    Radioisotope: Lu-177
    Theranostic Role: Therapeutic Agent & SPECT Imaging
    T1/2 (Half-Life): 6.7 Days
    Decay Mode: BETA, GAMMA
    Energy: Eβeta max 497 keV, Gamma 113-208 keV
    Range: In Tissue: 0.25-2mm
    Decay Daughters: Hf177
    Status: FDA Approvals: PLUVICTO® (2022), LUTATHERA® (2017)
  • LUTETIUM-177
Target(s):
  • CAIX
Ligand: Small Molecules

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