IDE196

Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions

Ensayo de IDEAYA Biosciences, Inc. en Metastatic Uveal Melanoma · Cutaneous Melanoma · Colorectal Cancer · Other Solid Tumors (del registro, en inglés).

Más ensayos de: Cáncer colorrectal.

Fase: Fase 1/2
Estado: Reclutando pacientes
Participantes: 336
Centros: 15
Fin del objetivo primario: ene 2027

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en jun 2019.

Qué mide

Dose-limiting Toxicity (DLT) (28 days following first dose of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib) (del registro, en inglés)

Qué se prueba

Se evalua la seguridad y actividad antitumoral de IDE196, solo o combinado con binimetinib o crizotinib, en pacientes con tumores solidos con mutaciones GNAQ o GNA11 o fusiones PRKC.

Lo que dice el documentoevaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors.

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 registroThis is a Phase 1/2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors. Phase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 (dose escalation - binimetib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 (dose escalation - crizotinib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and crizotinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Evaluation of safety and efficacy across multiple doses may be explored in the dose optimization part of the study. Crizotinib monotherapy with crossover to combination cohort may be assessed for safety and to show the contribution of each study drug to anti-tumor activity. As of Protocol Amendment 10, Phase 1, Phase 2 dose expansion in IDE196 monotherapy, and Phase 2 dose expansion of IDE196 in combination with binimetinib have been fully enrolled. There were no patients enrolled in the crizotinib monotherapy cohorts.

Más ensayos de IDYA

Ensayo	Fase	Estado	Lectura de resultados
IDE-161	Fase 1	En marcha, sin reclutar	oct 2026 (prevista)
IDE397	Fase 1	En marcha, sin reclutar	ene 2027 (prevista)
IDE196	Fase 2/3	En marcha, sin reclutar	ene 2027 (prevista)
Darovasertib	Fase 2	En marcha, sin reclutar	abr 2027 (prevista)
IDE034	Fase 1	Reclutando pacientes	jul 2027 (prevista)
IDE892	Fase 1	Reclutando pacientes	abr 2028 (prevista)

Todos los de IDYA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03947385), actualizada en jun 2026.