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. |
| NCT06084338 ↗ | Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc | Recruiting | VA Office of Research and Development | Phase 2 | 2023-12-14 | This trial tests if the combination of comprehensive metastasis directed therapy delivered by a precision form of external beam radiotherapy (stereotactic ablative radiotherapy), combined with PSMA targeted radiopharmaceutical therapy and cessation of castration, and then followed by testosterone replacement, is an effective treatment for metastatic castration resistant prostate cancer. All patients will be treated with stereotactic ablative radiotherapy and PSMA targeted radiopharmaceutical therapy with cessation of castration. Half of patients are randomized to either receive, or not receive, subsequent testosterone replacement. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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