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Trials
ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC

trialsTrialActive

ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC

A phase 1/2 trial of Gotistobart, Lutetium-177 vipivotide tetraxetan in prostate cancer, run by OncoC4, Inc., active and no longer recruiting.

Also called: PRESERVE-006

Overview Connected5

Overview

ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC is a phase 1/2 interventional study registered as NCT05682443 by OncoC4, Inc., with 148 participants enrolled, started 2023-12-11 and due to reach its primary completion in 2026-11-30. Interventions recorded: ONC-392 low, ONC-392 high, lutetium Lu 177 vipivotide tetraxetan. Conditions listed: Metastatic Castration-resistant Prostate Cancer. No results are recorded here; the registry entry is the source.

Setting

Randomized Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Progressed on Androgen Receptor (AR) Pathway Inhibition

Phase

Phase 1/2

Sponsor

OncoC4, Inc.

Registry

Started

2023-12-11

Enrolled

148 enrolled

Connected

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cancers

Metastatic castration-resistant prostate cancer Prostate cancer

drugs

Phase 3monoclonal antibody

ApprovedRadioligand therapy (beta)

Lutetium-177 vipivotide tetraxetan · Pluvicto

companies

Evidence strength24/100 · Preliminary

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 1/2+8
148 enrolled+11
No structured primary endpoint0
Result: active0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-18 · Jude Gomila · Add 115 registry trial acronyms from the CT.gov acronym f… · diff · file

Sources & links

ClinicalTrials.gov NCT05682443

Data

JSON ·

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Cancers

Prostate cancer
Metastatic castration-resistant prostate cancer

Products

Gotistobart
Lutetium-177 vipivotide tetraxetan

Companies

OncoC4

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

Model panel commentary is coming to this page: machine commentary, not clinical review.

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