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

Program Status

Active, not 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
Active, not recruiting
UCLA
Los Angeles, California 90095
Active, not recruiting
UCSD
San Diego, California 92037
Active, not recruiting
UCSF
San Francisco, California 94143
Active, not recruiting
Yale
New Haven, Connecticut 06510
Active, not recruiting
University of Miami
Miami, Florida 33136
Active, not recruiting
Ocala Oncology Center
Ocala, Florida 34474
Active, not recruiting
University of Chicago Medical Center
Chicago, Illinois 60637
Active, not recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
Active, not recruiting
Dana Farber Cancer Institute
Boston, Massachusetts 02215
Active, not recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
Active, not recruiting
Washington University
St Louis, Missouri 63110
Active, not recruiting
Rutgers
New Brunswick, New Jersey 08901
Active, not recruiting
NYU
New York, New York 10016
Active, not recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
Active, not recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
Active, not recruiting
Providence Cancer Institute Franz Clinic
Portland, Oregon 97213
Active, not recruiting
Sarah Cannon Research Institute
Nashville, Tennessee 37203
Active, not recruiting
Intermountain Health
Murray, Utah 84107
Active, not recruiting
Virginia Commonwealth
Richmond, Virginia 23298
Active, not recruiting

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

2025-09-10