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Dalutrafusp alfa
Study of Dalutrafusp Alfa (Formerly GS-1423) in Participants With Advanced Solid Tumors
Ensayo de GILEAD SCIENCES, INC. en Tumor solido avanzado.
Más ensayos de: Tumor sólido avanzado.
- Fase
- Fase 1
- Estado
- Interrumpido
- Participantes
- 22
- Centros
- 4
- Fin del objetivo primario
- oct 2020
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en jun 2019.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The decision to discontinue the study was made based on the totality of the clinical, pharmacokinetic, and pharmacodynamic findings. No safety concerns were observed.».
Qué mide
Phase 1a Part A: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs), Graded Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) (Baseline up to 28 days) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroFor Phase 1a Part A, the primary objectives are to assess safety and tolerability and to define the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of dalutrafusp alfa (formerly GS-1423) monotherapy in participants with advanced solid tumors. For Phase 1a Part B, the primary objective is to assess safety and tolerability of dalutrafusp alfa monotherapy in participants with advanced solid tumors. For Phase 1b Cohort 1 safety run-in, the primary objective is to assess safety and tolerability and to define the DLT and MTD or RP2D of dalutrafusp alfa in combination with a chemotherapy regimen in participants with advanced gastric or gastroesophageal junction adenocarcinoma. For Phase 1b Cohort 1 post safety run-in, the primary objective is to assess the preliminary efficacy of dalutrafusp alfa in combination with a chemotherapy regimen in participants with advanced gastric or gastroesophageal junction adenocarcinoma, as assessed by the confirmed objective response rate (ORR). For Phase 1b Cohort 2, the primary objective is to assess safety and tolerability of dalutrafusp alfa monotherapy in participants with advanced solid tumors.
Más ensayos de GILD
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Tenofovir DF | Fase 3 | En marcha, sin reclutar | ago 2017 (real) |
| Oral Lenacapavir · CAPELLA | Fase 2/3 | En marcha, sin reclutar | oct 2020 (real) |
| Sacituzumab Govitecan-hziy | Fase 2 | En marcha, sin reclutar | ago 2021 (real) |
| Sacituzumab Govitecan-hziy · EVOKE-01 | Fase 3 | En marcha, sin reclutar | nov 2023 (real) |
| ISL | Fase 2 | En marcha, sin reclutar | dic 2023 (real) |
| Oral Lenacapavir · PURPOSE 1 | Fase 3 | En marcha, sin reclutar | may 2024 (real) |
Todos los de GILD, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03954704), actualizada en feb 2023.