A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
Market
0.0%
Details
- Resolved Date
- 11/12/25
- Study Completion
- 3/1/26
- Company
- MacroGenics
- Ticker
- MGNX
- Type
- Trial Status
- Active Not Recruiting
- Trial Size
- 154
- Volume
- $0
- NCT
- NCT05848011
- Drug Description
- The purpose of this study is to determine whether the amount of time before disease progression can be prolonged in participants with metastatic castration-resistant prostate cancer (MCRPC) who receive lorigerlimab in addition to the standard of care (SOC) of docetaxel and prednisone. About 150 participants with mCRPC will be enrolled. Participants will be randomized in a 2:1 ratio to receive lorigerlimab with docetaxel and prednisone (experimental arm) or docetaxel and prednisone alone (standard-of-care arm). Lorigerlimab+docetaxel or docetaxel will be administered intravenously (IV) in clinic on Day 1 of each 3-week cycle. Prednisone will be administered orally twice daily. Lorigerlimab will be administered for up to 35 cycles. Docetaxel and prednisone will be administered up to 10 cycles until treatment discontinuation criteria are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI) and prostate-specific antigen (PSA) blood tests. Participants will be asked to complete questionnaires about their health and well-being. Routine examinations and blood tests will be performed and evaluated by the study doctor. Participants who have disease progression standard-of-care arm have the option of continuing on the study to receive lorigerlimab monotherapy.
Resolution Evidence
- Outcome
- NO
- Status
- Resolved
- Settlement Date
- 4/1/26 UTC
- Executive Summary
MacroGenics publicly tied the Phase 2 LORIKEET trial (NCT05848011) to a negative interim readout: it said the study’s experimental arm was not expected to achieve the primary rPFS goal versus control, and the company ended further prostate-cancer development.
Sources
Sponsorir.macrogenics.com11/12/25
MacroGenics Reports Third Quarter 2025 Financial Results and Provides Update on Corporate Progress
Company said that after reviewing interim LORIKEET data, it would not pursue further prostate-cancer development; with an Oct. 17, 2025 cutoff, the experimental arm was not expected to reach the primary rPFS goal vs control.
View source
ClinicalTrialsclinicaltrials.gov12/1/25
Study Details | NCT05848011 | A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov identifies NCT05848011 as the Phase 2 randomized study of lorigerlimab plus docetaxel/prednisone versus docetaxel/prednisone in metastatic castration-resistant prostate cancer.
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