Calendario›MGNX›lorigerlimab
lorigerlimab
A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
Ensayo de MACROGENICS INC en Androgen-Independent Prostatic Cancer · Androgen-Independent Prostatic Neoplasms · Prostate Cancer Recurrent · Androgen-Insensitive Prostatic Cance · Androgen-Resistant Prostatic Cancer · Hormone Refractory Prostatic Cancer · Immunotherapy · Immune Checkpoint Inhibitor · Inhibitory Checkpoint Molecule (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 154
- Centros
- 61
- Fin del objetivo primario
- feb 2026
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en sep 2023.
Qué mide
Median radiographic progression free survival (rPFS) determined by investigator review. (Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe 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.
Más ensayos de MGNX
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| MGC028 | Fase 1 | Reclutando pacientes | nov 2026 (prevista) |
| MGD024 | Fase 1 | En marcha, sin reclutar | nov 2026 (prevista) |
| Lorigerlimab | Fase 2 | Reclutando pacientes | jul 2027 (prevista) |
| MGC026 Dose Escalation | Fase 1 | Reclutando pacientes | may 2028 (prevista) |
| MGC030 | Fase 1 | Aún sin reclutar | sep 2028 (prevista) |
| vobramitamab duocarmazine | Fase 1 | Completado | jun 2025 (real) |
Todos los de MGNX, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05848011), actualizada en may 2026.