PSMA Therapy and Immunotherapy in Kidney Cancer

PHASE1/PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 1, 2025

Primary Completion Date

January 31, 2031

Study Completion Date

January 31, 2032

Conditions
Metastatic Renal Cell CarcinomaMetastatic Clear Cell Renal Cell Carcinoma
Interventions
DRUG

Pembrolizumab

"Pembrolizumab will be administer at 400 mg IV every 6 weeks in combination with 177Lu-PNT2002 until the maximum tolerated dose of 177Lu-PNT2002 is reached during the dose escalation phase.~Pembrolizumab will be administer at 400 mg IV every 6 weeks for a maximum of 17 cycles (6 weeks in each cycle) during the dose expansion phase."

DRUG

177Lu-PNT2002

"177Lu-PNT2002 given intravenously every 8 weeks will be administered at 3.4 GBq, 6.1 Gbq, or 6.8 Gbq in combination with the standard dose of pembrolizumab 400 mg given intravenously every 6 weeks until the maximum tolerated dose is reached during the dose escalation phase.~177Lu-PNT2002 given intravenously every 8 weeks will be administered at the determined maximum tolerated dose for a maximum of 4 cycles in combination with the standard dose of pembrolizumab 400 mg given intravenously every 6 weeks for a maximum of 17 cycles."

DRUG

(F-18)-DCFPyL

Patients will be administered 18F-DCFPyL as a single bolus intravenous radioactive dose injection of 333 MBq (9 mCi) at screening, week 12 and week 24.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Lantheus Medical Imaging

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT06361810 - PSMA Therapy and Immunotherapy in Kidney Cancer | Biotech Hunter | Biotech Hunter