A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors

Estado del programa

Reclutamiento

Fase

Fase 1

Inmunoterapia previa permitida

Ensayo dirigido por el CRC

No

Etiquetas

MSI-H/ MMRd, MSS/ MMRp

Comentarios

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

Clinical Operations
CONTACTO
650-410-7588 clinops@asherbio.com

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

NCT ID

NCT05653882

Fecha en que se añadió el juicio

2022-12-16

Fecha de actualización

2024-12-09