Oral Administration of STC-15 in Subjects With Advanced Malignancies
Advanced Cancer · Advanced Solid Tumor · Cancer
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 1
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 42 Real
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
This Phase 1, multi-center, open-label, first-in-human study evaluates multiple ascending daily oral doses of STC-15 in Q3W treatment cycles in a 3+3 cohort design with dose levels determined by a modified Fibonacci algorithm. The study is designed to systematically assess safety and tolerability, pharmacokinetics, pharmacodynamics and clinical activity of STC-15 in adult subjects with advanced malignancies. Dose levels for further evaluation in expansion cohorts will be selected based on all available PK, pharmacodynamic, target engagement, efficacy, safety, and tolerability data including long-term safety data beyond dose limiting toxicities (DLTs). The study may be amended to evaluate STC-15 in combination with a Food and Drug Administration-approved standard of care treatment regimen, which could encompass targeted/chemotherapy, radiation therapy and/or immunotherapy with immune checkpoint blockers.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Key Inclusion Criteria:
- \> 18 years of age
- Histologic or cytologic confirmation of advanced malignancy that has failed standard of care (SOC) therapy and no further SOC therapy is available or the subject has declined additional SOC therapy
- Adequate organ and marrow function
- ECOG PS of 0 or 1
Key Exclusion Criteria:
- Treatment with any local or systemic antineoplastic therapy within 3 weeks prior to first dose of STC-15
- Major surgery or radiation within the 3 weeks
- Immune-related AEs from immunotherapy that required permanent discontinuation
- Central nervous system (CNS) disease involvement, or prior history of Grade ≥3 drug-related CNS toxicity.
- Active autoimmune disease that has required systemic treatment in the 2 years prior to Screening
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Sin asignación al azar
- Enmascaramiento
- Sin enmascaramiento
Dose Level 1
30mg capsules, daily administration for 3 week (21 day) cycles
Drug: STC-15
Dose Level 2
30mg capsules, MWF administration for 3 week (21 day) cycles
Drug: STC-15
Dose Level 3
100mg capsules, MWF administration for 3 week (21 day) cycles
Drug: STC-15
Dose Level 4
30mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles
Drug: STC-15
Dose Level 5
30mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles
Drug: STC-15
STC-15 DRUG
STC-15 oral capsules various dosing regimen in 3-week cycles
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Number of Participants With Related Treatment Emergent Adverse Events
Plazo: Screening through end of treatment, approximately 6 months
To evaluate the incidence, severity, and duration of related treatment emergent adverse events
Cmax (PK)
Plazo: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose on Cycle 1 Day 1 (C1D1)
To determine the Cmax concentration over a dosing interval
Tmax (PK)
Plazo: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose on C1D1
To determine the time to Cmax (Tmax)
Ctrough (PK)
Plazo: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours Pre-dose on Cycle 2 Day 1
To determine observed trough plasm concentration (Ctrough)
Terminal Elimination Half Life (PK)
Plazo: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose on C1D1
To determine the terminal elimination half-life (t½)
AUC (PK)
Plazo: For daily administration: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours on C1D1; for MWF administration: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours on C1D1.
To determine AUC in 1 dosing interval
Average Concentration (PK)
Plazo: For daily administration: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours on C1D1; for MWF administration: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours on C2D1.
To determine the average concentration over a dosing interval
Systemic Clearance (PK)
Plazo: For daily administration: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours on C1D1; for MWF administration: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours on C1D1.
To determine the systemic clearance
Volume of Distribution at Steady-state (PK)
Plazo: For daily administration: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours on C1D1; for MWF administration: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours on C1D1.
To determine the volume of distribution at steady-state (Vss)
Accumulation Ratio From First Dose to Steady-state (PK)
Plazo: For MWF administration: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours on C1D1 and C2D1.
To determine the accumulation ratio from first dose to steady-state
Medidas secundarias
Efficacy as Measured by RECIST 1.1 (DoR)
Plazo: Screening through disease progression, approximately 6 months
Determine the duration of response (DoR)
Efficacy as Measured by RECIST 1.1 (DCR)
Plazo: Screening through disease progression, approximately 6 months
Determine the disease control rate (DCR)
Efficacy as Measured by RECIST 1.1 (ORR)
Plazo: Screening through disease progression, approximately 6 months
Determine the objective response rate (ORR)
Recommended Phase 2 Dose (RP2D)
Plazo: Screening through 90 days after the last dose of STC-15, approximately 9 months
determine the RP2D for STC-15
Otras medidas
Assessment of m6A Modification of mRNA From Peripheral Blood
Plazo: Screening through Cycle 2 (each cycle is 21 days)
To evaluate the effect of STC-15 on METTL3 enzymatic activity
Assessment of Serum Cytokines Levels
Plazo: Screening through Cycle 2 (each cycle is 21 days)
To evaluate immunologic biomarkers in blood and tumor tissue
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (3)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
3 centros
Honor HealthScottsdale, Arizona, United StatesEstado desconocido
The University of Texas MD Anderson Cancer CenterHouston, Texas, United StatesEstado desconocido
South Texas Accelerated Research TherapeuticsSan Antonio, Texas, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- STORM Therapeutics LTD
- Inicio del estudio
- 15 nov 2022 Real
- Finalización primaria
- 30 ago 2024 Real
- Finalización del estudio
- 22 dic 2024 Real
- Primera publicación
- 18 oct 2022 Real
- Última actualización
- 9 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Phase 1 Study to Evaluate the Safety, PK, PD, and Clinical Activity of STC-15, a METTL-3 Inhibitor, in Subjects With Advanced Malignancies
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 9 nov 2026