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

Program Status

Recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

No

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

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.

Location Location Status
United States
City of Hope
Duarte, California 91010
Recruiting
UCLA
Los Angeles, California 90095
Recruiting
UCSF
San Francisco, California 94143
Recruiting
Yale
New Haven, Connecticut 06510
Recruiting
University of Miami
Miami, Florida 33136
Recruiting
Ocala Oncology Center
Ocala, Florida 34474
Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts 02215
Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
Recruiting
Washington University
Saint Louis, Missouri 63110
Recruiting
Rutgers
New Brunswick, New Jersey 08901
Recruiting
NYU
New York, New York 10016
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee 37203
Recruiting
Virginia Commonwealth
Richmond, Virginia 23298
Recruiting

Contacts

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

Inclusion Criteria

Inclusion Criteria:

* 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

Exclusion Criteria

Exclusion Criteria:

* 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

Date Trial Added

2022-12-16

Updated Date

2024-12-09