An Open-Label Phase 1a/1b Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of AB248 Alone or in Combination with Pembrolizumab in Adult Patients with Locally Advanced or Metastatic Solid Tumors

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objectives:

To assess the safety and tolerability of AB248 alone or in combination with pembrolizumab

Secondary Objectives:

To assess the preliminary antitumor effect of AB248 alone or in combination with pembrolizumab
To assess the PK of AB248 alone or in combination with pembrolizumab
To assess the relationship between AB248 PK and biomarkers of pharmacodynamic response to AB248 alone or in combination with pembrolizumab
To assess the immunogenicity of AB248 when administered alone or in combination with pembrolizumab

Eligibility

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:

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.

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices