A Study Evaluating AB248 Alone or in Combination with Pembrolizumab in Adult Patients with Solid Tumors
Purpose
This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of AB248 as monotherapy OR in combination with pembrolizumab in adult participants with locally advanced or metastatic solid tumors. The study will consist of a dose escalation and a dose expansion stage.
Conditions
- Solid Tumor
- Non Small Cell Lung Cancer
- Melanoma
- Squamous Cell Carcinoma of Head and Neck
- Renal Cell Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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. - Is expected to require any other form of antineoplastic therapy while on study
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental AB248 Monotherapy Dose-Escalation |
AB248 will be administered intravenously as a single agent |
|
|
Experimental AB248 + pembrolizumab Combination Dose-Escalation |
AB248 and pembrolizumab will be administered intravenously |
|
|
Experimental AB248 Monotherapy Indication Expansion |
AB248 will be administered intravenously as a single agent in disease specific cohorts |
|
|
Experimental AB248 + pembrolizumab Combination Indication Expansion |
AB248 and pembrolizumab will be administered intravenously in disease specific cohorts |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Asher Biotherapeutics, Inc.