Calendario›KRYS›KB707 · KYANITE-1
KB707 · KYANITE-1
A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
Ensayo de Krystal Biotech, Inc. en Lung Cancer, Non-small Cell · Lung Cancer Metastatic · Solid Tumor, Adult · Advanced Cancer · Lung Cancer (NSCLC) (del registro, en inglés).
Más ensayos de: Tumor sólido · Cáncer avanzado.
- Fase
- Fase 1/2
- Estado
- Reclutando pacientes
- Participantes
- 250
- Centros
- 14
- Fin del objetivo primario
- feb 2027
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en abr 2024.
Qué mide
To evaluate the safety and tolerability of inhaled KB707 based upon assessment of adverse events (AE) (del registro, en inglés) (hasta 36 meses)
Qué se prueba
Se evaluan seguridad, tolerabilidad, eficacia preliminar y efecto inmunologico de KB707, administrado por via inhalada, en adultos con tumores solidos avanzados que afectan a los pulmones, tanto en monoterapia como en combinacion con Keytruda o docetaxel en cancer de pulmon no microcitico avanzado o metastasico.
Lo que dice el documentoThis is a Phase 1/2, open-label, multicenter, dose escalation and expansion study designed to evaluate the safety, tolerability, preliminary efficacy, and immunologic effect of KB707. Monotherapy KB707 dose escalation and expansion cohorts enrolled adults with advanced solid tumor malignancies affecting the lungs who had progressed on standard of care therapy, cannot tolerate standard of care therapy, or refused standard of care therapy.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe Sponsor is developing KB707, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector designed to stimulate an anti-tumor immune response through the production of cytokines within the local tumor microenvironment in the lungs. KB707 is administered via nebulization, delivering the therapy directly through the airways to the lungs of subjects with advanced solid tumor malignancies. This is a Phase 1/2, open-label, multicenter, dose escalation and expansion study designed to evaluate the safety, tolerability, preliminary efficacy, and immunologic effect of KB707. Monotherapy KB707 dose escalation and expansion cohorts enrolled adults with advanced solid tumor malignancies affecting the lungs who had progressed on standard of care therapy, cannot tolerate standard of care therapy, or refused standard of care therapy. The dose escalation phase (Cohorts 1 and 2) evaluated KB707 monotherapy using a standard 3+3 design, followed by a dose expansion phase (Cohort 4) to further evaluate the selected dose. Subjects received inhaled KB707 weekly for three weeks, then every three weeks. The dose escalation portion of the study is now complete, and the selected dose is being evaluated in the expansion phase. Combination regimens with a selected (fixed) dose of KB707 are being evaluated in subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Subjects in Cohorts 5 and 6 are receiving inhaled KB707 once every 2 weeks (q2w), delivered in combination with Keytruda once every 6 weeks. Subjects in Cohort 7 are receiving inhaled KB707 in combination with docetaxel once every 3 weeks. All subjects will be treated until tumor progression, death, unacceptable toxicity, symptomatic deterioration, achievement of maximal response, subject choice, Investigator decision to discontinue treatment, or the Sponsor determines to terminate the study.
Más ensayos de KRYS
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| KB301 | Fase 1 | En marcha, sin reclutar | oct 2024 (real) |
| KB304 · Pearl-2 | Fase 1/2 | En marcha, sin reclutar | jul 2025 (prevista, ya pasada: sin actualizar en el registro) |
| A Natural History Study of Corneal Abrasions in Patients With Dystrophic Epidermolysis Bullosa (DEB) | no aplica | Reclutando pacientes | dic 2025 (prevista, ya pasada: sin actualizar en el registro) |
| KB408 · Serpentine-1 | Fase 1 | Reclutando pacientes | dic 2025 (prevista, ya pasada: sin actualizar en el registro) |
| KB111 · HALITE-1 | Fase 1 temprana | Reclutando pacientes | nov 2026 (prevista) |
| KB803 · IOLITE | Fase 3 | Reclutando pacientes | dic 2026 (prevista) |
Todos los de KRYS, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06228326), actualizada en oct 2025.