KB707

A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors

Ensayo de Krystal Biotech, Inc. en Cancer · Melanoma Stage III · Melanoma Stage IV · Cutaneous Melanoma (del registro, en inglés).

Más ensayos de: Cáncer.

Fase: Fase 1/2
Estado: Reclutando pacientes
Participantes: 240
Centros: 15
Fin del objetivo primario: jul 2027

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en oct 2023.

Qué mide

Percentage of adverse events (AEs) (del registro, en inglés) (hasta 36 meses)

Qué se prueba

Se evalua la seguridad y tolerabilidad de KB707 en adultos con tumores solidos avanzados o metastasicos que han progresado o no toleran el tratamiento estandar, asi como su combinacion con Opdualag en sujetos con melanoma irresecable o metastasico.

Lo que dice el documentoThe study will evaluate the safety and tolerability of KB707 in adults with locally advanced or metastatic solid tumors who have progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or for whom there is no standard of care therapy as well as the safety, tolerability, preliminary efficacy, and immunologic effect of KB707 administered in combination with Opdualag to subjects with unresectable or metastatic melanoma. Subjects in dose escalation (Cohorts 1 through 3) and dose expansion (Cohort 4) will receive intratumoral injections of KB707 approximately every three weeks.

Traducción automática (claude-sonnet-5), con la cita comprobada contra el documento y revisada por una persona.

Cómo lo describe el promotor

En el documentoEn inglés, del registroKB707-01 is a Phase 1/2, open-label, multicenter, dose escalation and expansion study. The study will evaluate the safety and tolerability of KB707 in adults with locally advanced or metastatic solid tumors who have progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or for whom there is no standard of care therapy as well as the safety, tolerability, preliminary efficacy, and immunologic effect of KB707 administered in combination with Opdualag to subjects with unresectable or metastatic melanoma. Subjects in dose escalation (Cohorts 1 through 3) and dose expansion (Cohort 4) will receive intratumoral injections of KB707 approximately every three weeks. Cohorts 1 through 4 are closed to new enrollment. Dose expansion Cohort 5 and Cohort 6 will evaluate subjects with advanced melanoma. Subjects in Cohort 5 will receive intratumoral injections of KB707 biweekly (q2w), delivered in combination with Opdualag (dosed every q4w per prescribing information). Subjects in Cohort 6 will receive intratumoral injections of KB707 biweekly (q2w), delivered in combination with Keytruda (dosed every q6w per prescribing information). All subjects will be treated until disease 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

Ensayo	Fase	Estado	Lectura de resultados
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 (NCT05970497), actualizada en may 2025.