Study: NCT06361810

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pembrolizumab
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pembrolizumab
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 177Lu-PNT2002
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 177Lu-PNT2002
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 177Lu-PNT2002
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 177Lu-PNT2002
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: (F-18)-DCFPyL
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: (F-18)-DCFPyL
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: (F-18)-DCFPyL
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: (F-18)-DCFPyL
Description: 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.