Phase 2 Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC
Status:
Not yet recruiting
Trial end date:
2026-12-30
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to examine the safety and efficacy of ONC-392 in
combination with lutetium Lu 177 vipivotide tetraxetan in metastatic castration resistant
prostate cancer patient who have disease progressed on androgen receptor pathway inhibition.
The main questions it aims to answer are (1) whether it is safe to combine ONC-392 with
lutetium Lu 177 vipivotide tetraxetan, (2) whether the combination increases the radiographic
progression free survival (rPFS).
Participants will be randomized to two arms in 2:1 ratio. In experimental arm, they will be
given ONC-392 10 mg/kg IV infusion, once every 4 weeks for up to 13 cycles or approximately
one year, together with lutetium Lu 177 vipivotide tetraxetan 7.4 GBq IV, once every 6 weeks
for up to 6 cycles. In active control arm, they will be given standard of care treatment with
lutetium Lu 177 vipivotide tetraxetan 7.4 GBq IV, once every 6 weeks for up to 6 cycles.