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

Launched by ASHER BIOTHERAPEUTICS, INC. · Dec 8, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called AB248, both on its own and in combination with another drug called pembrolizumab, for adults with specific types of cancer, including lung cancer, melanoma, and kidney cancer. This is a phase I study, meaning it's one of the first times this treatment is being tested in people to see how safe it is and if it can help fight these cancers. The trial will involve increasing doses of the drugs to find the right amounts that are both safe and effective.

To participate in this study, patients must be at least 18 years old and have a measurable cancer that is considered advanced or not treatable with standard methods. They should also have good overall health, as determined by certain medical tests. Participants will receive the study treatment and will be closely monitored by medical professionals throughout the trial. It's important to note that some patients may not be eligible, such as those with certain infections, autoimmune diseases, or recent cancer treatments. Overall, this trial aims to gather important information that could help improve future cancer treatments.

Gender

ALL

Eligibility 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:
• • 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

Trial Officials