Estado del programa
ReclutamientoFase
Fase 1Inmunoterapia previa permitida
SíEnsayo dirigido por el CRC
NoEtiquetas
MSI-H/ MMRd, MSS/ MMRpComentarios
AB248: CD8+ T cell-selective IL-2 with over 500-fold preference for CD8+ T cells over other immune cell types.
Pembrolizumab: anti PD-1, immunotherapy.
AB248 alone or in combination with pembrolizumab. Prior anti PD-1/ L1 checkpoint inhibitor seems OK, but not prior immunotherapy that targets IL-2, IL-7, or IL-15 receptors. For solid tumors.
Ubicación | Situación |
---|---|
Estados Unidos | |
Ciudad de la Esperanza Duarte, California 91010 |
Reclutamiento |
UCLA Los Ángeles, California 90095 |
Reclutamiento |
UCSF San Francisco, California 94143 |
Reclutamiento |
Yale New Haven, Connecticut 06510 |
Reclutamiento |
University of Miami Miami, Florida 33136 |
Reclutamiento |
Centro de Oncología de Ocala Ocala, Florida 34474 |
Reclutamiento |
Hospital General de Massachusetts Boston, Massachusetts 02114 |
Reclutamiento |
Instituto Oncológico Dana Farber Boston, Massachusetts 02215 |
Reclutamiento |
Karmanos Cancer Institute Detroit, Michigan 48201 |
Reclutamiento |
Universidad de Washington San Luis, Missouri 63110 |
Reclutamiento |
Rutgers New Brunswick, Nueva Jersey 08901 |
Reclutamiento |
NYU Nueva York, Nueva York 10016 |
Reclutamiento |
Centro Oncológico Memorial Sloan Kettering Nueva York, Nueva York 10065 |
Reclutamiento |
Centro Oncológico Integral Lineberger de la UNC Chapel Hill, Carolina del Norte 27599 |
Reclutamiento |
Instituto de Investigación Sarah Cannon Nashville, Tennessee 37203 |
Reclutamiento |
Virginia Commonwealth Richmond, Virginia 23298 |
Reclutamiento |
Contactos
Criterios de inclusión
Criterios de inclusión:
* Age ≥18 years of age at the time consent is signed.
* Has adequate end organ function per laboratory testing.
* Pregnancy prevention requirements
* Has measurable disease per RECIST 1.1 as assessed by the local site Investigator/radiology.
* Has a performance status of 0 or 1 on Eastern Cooperative Oncology Group scale.
* Histologic documentation of incurable, locally advanced or metastatic tumor of the type being evaluated in individual cohorts
Criterios de exclusión
Criterios de exclusión:
* Has a diagnosis of immunodeficiency.
* Has a history of a previous, additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years.
* Has known active CNS metastases and/or carcinomatous meningitis.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
* Has an active infection requiring systemic therapy.
* Inability to comply with study and follow-up procedures.
* Has had a severe hypersensitivity reaction (Grade ≥3) to treatment with pembrolizumab, another monoclonal antibody, or has history of any hypersensitivity to any components of the study treatments or any of their excipients.
* Has received prior systemic anticancer therapy including investigational agents within 4 weeks (or, if shorter, within 5 half-lives for kinase inhibitors) prior to first dose of study treatment.
* Has received prior radiotherapy within 2 weeks of start of study treatment or has had a history of radiation pneumonitis.
* Receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment.
* Has received previous treatment with another agent targeting the IL-2, IL-7, or IL-15 receptors.
* Is expected to require any other form of antineoplastic therapy while on study