Phase 1 Study of VT-101 in Advanced Ovarian Cancer
A Phase 1 Dose-Finding, Safety, and Preliminary Clinical Activity Study of VT-101 in Advanced Ovarian Cancer
This Phase 1, open-label study will evaluate VT-101, an investigational small-molecule therapy, in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer. The primary objectives are to assess the safety, tolerability, and pharmacokinetic profile of VT-101 and to identify a recommended dose for further study. Secondary and exploratory objectives include evaluation of preliminary antitumor activity and characterization of treatment-related effects in participants with limited standard treatment options.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a Phase 1, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of VT-101 in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer. Eligible participants must have disease that has progressed following prior therapy or have exhausted, refused, become intolerant of, or are otherwise ineligible for available standard treatment options.
Participants will receive VT-101 administered according to a dose-escalation design to evaluate the safety profile of escalating dose levels and to identify an appropriate dose and schedule for further clinical development. Safety assessments will include the evaluation of adverse events, serious adverse events, dose-limiting toxicities, clinical laboratory parameters, physical examinations, vital signs, and other protocol-specified assessments.
Pharmacokinetic analyses will be performed to characterize the absorption, distribution, metabolism, and elimination of VT-101. Antitumor activity will be assessed using protocol-defined efficacy endpoints, including tumor response and disease control measures. Exploratory analyses may evaluate biomarkers and other factors associated with treatment response and clinical outcomes.
The information generated from this study will support determination of the safety profile, pharmacokinetic characteristics, and recommended dose of VT-101 for subsequent clinical investigation in patients with advanced epithelial ovarian cancer.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Michael Goodheart, MD
- Número de teléfono: +1 319 356 2015
- Correo electrónico: michael-goodheart@uiowa.edu
Ubicaciones de estudio
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- Reclutamiento
- University of Iowa Health Care
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Contacto:
- Michael Goodheart, MD
- Correo electrónico: michael-goodheart@uiowa.edu
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Contacto:
- Kerri Fitch
- Número de teléfono: (319) 467-5838
- Correo electrónico: kerri-fitch@uiowa.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
ELIGIBILITY CRITERIA
Inclusion Criteria:
- Female participant
- Age ≥ 18 years
- Histologically confirmed advanced, recurrent, or relapsed epithelial ovarian cancer
- Has received prior standard therapy for ovarian cancer, OR has refused standard therapy, OR is intolerant to standard therapy, OR is not eligible for standard therapy
- ECOG Performance Status of 0, 1, or 2
- Adequate bone marrow, liver, and kidney function as defined by the protocol
- Able to comply with study procedures and provide informed consent
- For women of childbearing potential: agrees to use protocol-required contraception and meets pregnancy testing requirements
Exclusion Criteria (high-level):
- Does not meet the inclusion criteria
- Medical conditions or laboratory abnormalities that would make study participation unsafe
- Other protocol-defined exclusions as determined by the investigator
Sex:
• Female only
Age:
- 18 years and older
- No upper age limit specified
Healthy Volunteers:
- No
- Healthy volunteers are not eligible
- Participants must have advanced, recurrent, or relapsed epithelial ovarian cancer
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: VT-101 Dose Escalation and Expansion
Participants will receive VT-101 by intraperitoneal administration once weekly for four doses on Days 1, 8, 15, and 22. During Phase I, doses will be escalated using a standard 3+3 design, starting at 1 × 10⁸ microvesicles (MVs) per dose, followed by 1 × 10⁹ and 1 × 10¹⁰ MVs per dose. Once the maximum tolerated dose (MTD) is determined, enrollment at the MTD will be expanded to include 10 patients in the efficacy evaluation. Patients treated at the MTD during Phase I will count toward this total. |
VT-101 is an investigational therapy consisting of autologous M1 macrophage-derived vesicles generated through membrane fragmentation. VT-101 is administered intraperitoneally via an implanted port over approximately 45 minutes, once weekly on Days 1, 8, 15, and 22, for four doses. Phase I dose escalation follows a standard 3+3 design, beginning at 1 × 10⁸ vesicles per dose and escalating to 1 × 10⁹ and 1 × 10¹⁰ vesicles per dose. Each participant receives the same dose level. After the maximum tolerated dose is established, an expansion cohort will evaluate preliminary efficacy at that dose. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With Dose-Limiting Toxicities (DLTs)
Periodo de tiempo: From the first dose through 14 days after the Day 22 dose. This reflects the Phase I primary endpoint and the protocol's specified toxicity-monitoring window.
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Number of participants experiencing dose-limiting toxicities (DLTs) during Phase I dose escalation. The maximum tolerated dose (MTD) will be defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT. |
From the first dose through 14 days after the Day 22 dose. This reflects the Phase I primary endpoint and the protocol's specified toxicity-monitoring window.
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Overall Response Rate (ORR)
Periodo de tiempo: Beginning 1 month after the fourth dose (±7 days), then every 8 weeks for the first 12 months and every 12 weeks thereafter until disease progression or the end of study.
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Proportion of participants achieving a complete response (CR) or partial response (PR), assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Participants who do not meet the criteria for an objective response will be considered non-responders. |
Beginning 1 month after the fourth dose (±7 days), then every 8 weeks for the first 12 months and every 12 weeks thereafter until disease progression or the end of study.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of Participants With a ≥50% Reduction in CA-125
Periodo de tiempo: From baseline to after 4 doses of VT-101 (Days 1, 8, 15, and 22).
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Proportion of participants who achieve at least a 50% reduction in CA-125 levels relative to baseline. |
From baseline to after 4 doses of VT-101 (Days 1, 8, 15, and 22).
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Progression-Free Survival (PFS)
Periodo de tiempo: From treatment initiation until disease progression or death, with tumor imaging beginning 1 month after the fourth dose and then every 8 weeks for the first 12 months and every 12 weeks thereafter.
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Time from treatment initiation to the first documented disease progression or death from any cause, whichever occurs first. Participants without documented progression or death will be censored at their last radiographic assessment for progression. |
From treatment initiation until disease progression or death, with tumor imaging beginning 1 month after the fourth dose and then every 8 weeks for the first 12 months and every 12 weeks thereafter.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michael Goodheart, MD, University of Iowa
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
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema endocrino
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Neoplasias por tipo histológico
- Enfermedades Genitales Femeninas
- Neoplasias de glándulas endocrinas
- Neoplasias Glandulares y Epiteliales
- Enfermedades Ováricas
- Enfermedades anexiales
- Neoplasias Genitales Femeninas
- Trastornos gonadales
- Carcinoma
- Carcinoma Epitelial De Ovario
- Neoplasias Ováricas
Otros números de identificación del estudio
- 202608053
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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