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MGD013 monotherapy
MGD013 Monotherapy and Combination With Brivanib Dose Escalation and Expansion Study in Advanced Liver Cancer Patients
Ensayo de Zai Lab Ltd en Advanced Hepatocellular Carcinoma (HCC) (del registro, en inglés).
- Fase
- Fase 1/2
- Estado
- Interrumpido
- Participantes
- 89
- Centros
- 1
- Fin del objetivo primario
- abr 2022
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en abr 2020.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Due to the rapid shifting of liver cancer disease landscape and the company's adjustment of development strategy.».
Qué mide
Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) (The first two cycles (Cycle 1 and Cycle 2) of the study treatment(s). A cycle lasted for two weeks (14 days) in the study.) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study consists of two parts: Phase I is a dose escalation study to determine the Recommended Phase II Dose (RP2D) of MGD013 monotherapy and that of MGD013 when in combination with Brivanib Alaninate (ZL-2301) in subjects with advanced liver cancer (including hepatocellular carcinoma and intrahepatic cholangiocarcinoma). Phase II is a dose expansion study and consists of two parts: Part 1 is to assess the safety and efficacy of MGD013 monotherapy and MGD013 in combination with ZL-2301 in subjects with advanced hepatocellular carcinoma (HCC); in Part 2, a therapeutic method (MGD013 monotherapy or MGD013 in combination with ZL-2301, determined by the sponsor according to the obtained data) will be selected for dose expansion study in HCC subjects who have previously failed immune checkpoint inhibitor treatment, to further evaluate the safety and efficacy of the study treatments in the specific group of subjects.
Más ensayos de ZLAB
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| ZL-1503 | Fase 1 | Aún sin reclutar | feb 2027 (prevista) |
| ZL-1109 | Fase 3 | En marcha, sin reclutar | mar 2027 (prevista) |
| ZL-1310 | Fase 1 | Reclutando pacientes | may 2027 (prevista) |
| ZL-1310 | Fase 1/2 | Reclutando pacientes | ago 2027 (prevista) |
| Xanomeline and trospium chloride | no aplica | Aún sin reclutar | ago 2027 (prevista) |
| ZL-1503 | Fase 1 | Reclutando pacientes | dic 2027 (prevista) |
Todos los de ZLAB, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04212221), actualizada en jun 2024.