- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07703878
A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors
A Phase 1 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of GS-1206 in Adults With Solid Tumors
The goal of this clinical study is to learn more about the study drug GS-1206, including its safety, tolerability, and antitumor activity in adult participants with solid tumors.
Descripción general del estudio
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Gilead Clinical Study Information Center
- Número de teléfono: 1-833-445-3230 (GILEAD-0)
- Correo electrónico: GileadClinicalTrials@gilead.com
Ubicaciones de estudio
-
-
Michigan
-
Grand Rapids, Michigan, Estados Unidos, 49546
- Reclutamiento
- START Midwest, LLC
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Texas
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Dallas, Texas, Estados Unidos, 75039
- Reclutamiento
- NEXT Oncology Dallas
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San Antonio, Texas, Estados Unidos, 78229
- Reclutamiento
- NEXT Oncology
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San Antonio, Texas, Estados Unidos, 78229
- Reclutamiento
- START San Antonio, LLC
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Key Inclusion Criteria:
- All individuals must have a tumor with protocol-specified mutation as determined by local health-authority approved test.
- For Part A (including backfill cohorts): Individuals with histologically confirmed advanced or metastatic solid tumors who have progressed following treatment in the advanced or metastatic setting known to confer clinical benefit, unless the individual refused, is intolerant to, or is not eligible for standard-of-care (SOC) treatment.
- For Part B dose expansion, individuals with protocol-specified tumor types will be enrolled.
Key Exclusion Criteria:
-
Use of any of the therapies listed below within the specified time frames:
- Investigational drugs (drugs not marketed for any indication) within 28 days prior to Cycle 1 Day 1.
- Anticancer biologic agent or immunotherapy within 28 days prior to Cycle 1 Day 1.
- Anticancer chemotherapy or targeted approved small molecule therapy within 21 days prior to Cycle 1 Day 1, or 42 days for nitrosoureas or mitomycin.
- Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started within 14 days prior to planned Cycle 1 Day 1 are not permitted. Exceptions: hormonal therapy, bisphosphonates, somatostatin analogues, and leuprolide are permitted if started at least 14 days prior to Cycle 1 Day 1.
- Major surgery (excluding minor procedures, eg, placement of vascular access, gastrointestinal/biliary stent, biopsy) within 28 days prior to Cycle 1 Day 1, and any toxicity or complications have recovered to Grade 1 or less.
- Radiation therapy within 21 days prior to Cycle 1 Day 1. Exception: limited (eg, pain palliation) radiation therapy is allowed if any radiation associated toxicity is resolved to Grade 1 or less, and the radiation is not administered to a target lesion.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Part A: Dose Escalation
Participants will receive escalating doses of GS-1206 monotherapy one time daily up to 35 cycles. |
Administered Orally |
|
Experimental: Part B: Dose Expansion
Participants will be enrolled in different indication specific cohorts. Participants will receive GS-1206 monotherapy at the recommended dose one time daily up to 35 cycles. |
Administered Orally |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)
Periodo de tiempo: First dose up to 21 days post first dose
|
First dose up to 21 days post first dose
|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Periodo de tiempo: First dose date up to 30 days post last dose (Up to 3 years)
|
First dose date up to 30 days post last dose (Up to 3 years)
|
|
Percentage of Participants Experiencing Clinical Laboratory Abnormalities Based National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Periodo de tiempo: First dose date up to 30 days post last dose (Up to 3 years)
|
First dose date up to 30 days post last dose (Up to 3 years)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Plasma Concentrations of GS-1206 and its Metabolites After Single Dose and Repeated Dose Administration
Periodo de tiempo: Predose and postdose up to end of treatment (up to 2 years)
|
Predose and postdose up to end of treatment (up to 2 years)
|
|
|
Pharmacokinetic (PK) Parameter: Cmax of GS-1206 and its Metabolites
Periodo de tiempo: Up to 2 years
|
Cmax is defined as the maximum observed concentration of drug |
Up to 2 years
|
|
PK Parameter: Tmax of GS-1206 and its Metabolites
Periodo de tiempo: Up to 2 years
|
Tmax is defined as the time (observed time point) of Cmax |
Up to 2 years
|
|
PK Parameter: AUC0-24h of GS-1206 and its Metabolites
Periodo de tiempo: Up to 2 years
|
AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 |
Up to 2 years
|
|
Objective Response Rate (ORR)
Periodo de tiempo: Up to 3 years
|
ORR is defined as the percentage of participants who have measurable disease at baseline and have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and assessed by the investigator at the local site. |
Up to 3 years
|
|
Duration of Response (DOR)
Periodo de tiempo: Up to 3 years
|
DOR is defined as the measurement from the time of first response (CR or PR) as assessed by the investigator at local site, per RECIST v1.1 until the date of first documented disease progression or death, whichever occurs first. |
Up to 3 years
|
|
Best Overall Response (BOR)
Periodo de tiempo: Up to 3 years
|
BOR is defined as the best response recorded from first dosing date until disease progression identified by RECIST v1.1, death, or the participant discontinues study treatment, whichever occurs first. |
Up to 3 years
|
|
Progression-Free Survival (PFS)
Periodo de tiempo: Up to 3 years
|
PFS is defined as the time from first dosing date until disease progression or death from any cause, whichever comes first as measured per RECIST v1.1. |
Up to 3 years
|
|
Disease Control Rate (DCR)
Periodo de tiempo: Up to 3 years
|
DCR is defined as the measurement by the percentage of participants who achieve confirmed response of CR or PR or stable disease. |
Up to 3 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Gilead Study Director, Gilead Sciences
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- GS-US-723-7652
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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