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Last Updated: April 20, 2024

~ Buy the PLUVICTO (lutetium lu-177 vipivotide tetraxetan) Drug Profile, 2024 PDF Report in the Report Store ~

CLINICAL TRIALS PROFILE FOR PLUVICTO


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All Clinical Trials for PLUVICTO

Trial ID Title Status Sponsor Phase Start Date Summary
NCT05682443 ↗ Phase 2 Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC Not yet recruiting Prostate Cancer Clinical Trials Consortium Phase 2 2023-05-01 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.
NCT05682443 ↗ Phase 2 Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC Not yet recruiting OncoC4, Inc. Phase 2 2023-05-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PLUVICTO

Condition Name

Condition Name for PLUVICTO
Intervention Trials
Metastatic Castration-resistant Prostate Cancer 1
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Condition MeSH

Condition MeSH for PLUVICTO
Intervention Trials
Prostatic Neoplasms 1
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Clinical Trial Progress for PLUVICTO

Clinical Trial Phase

Clinical Trial Phase for PLUVICTO
Clinical Trial Phase Trials
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for PLUVICTO
Clinical Trial Phase Trials
Not yet recruiting 1
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Clinical Trial Sponsors for PLUVICTO

Sponsor Name

Sponsor Name for PLUVICTO
Sponsor Trials
Prostate Cancer Clinical Trials Consortium 1
OncoC4, Inc. 1
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Sponsor Type

Sponsor Type for PLUVICTO
Sponsor Trials
Other 1
Industry 1
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