ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC - Trial NCT05682443
Access comprehensive clinical trial information for NCT05682443 through Pure Global AI's free database. This Phase 2 trial is sponsored by OncoC4, Inc. and is currently Not yet recruiting. The study focuses on Metastatic Castration-resistant Prostate Cancer. Target enrollment is 90 participants.
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Study Focus
Sponsor & Location
OncoC4, Inc.
Timeline & Enrollment
Phase 2
May 01, 2023
Dec 30, 2026
Primary Outcome
Radiographic progression free survival (rPFS)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05682443
Non-Device Trial