Evaluating AB248 alone or with pembrolizumab in adults with solid tumors
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
This study is testing a new drug called AB248, alone and with another drug called pembrolizumab, to see if it can help adults with advanced solid tumors feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 552 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Asher Biotherapeutics, Inc. Industry-sponsored |
| Drugs / interventions | pembrolizumab, radiation |
| Locations | 20 sites (Duarte, California and 19 other locations) |
| Trial ID | NCT05653882 on ClinicalTrials.gov |
What this trial studies
This phase I, first-in-human study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of AB248, both as a standalone treatment and in combination with pembrolizumab, in adult patients with locally advanced or metastatic solid tumors. The study will include a dose escalation phase followed by a dose expansion phase to better understand the drug's effects. Participants will be closely monitored for any adverse reactions and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with incurable, locally advanced or metastatic solid tumors and a performance status of 0 or 1.
Not a fit: Patients with active autoimmune diseases, immunodeficiencies, or those with certain types of previous malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with difficult-to-treat solid tumors.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Duarte, California and 19 other locations
- City of Hope — Duarte, California, United States (Recruiting)
- UCLA — Los Angeles, California, United States (Recruiting)
- UCSD — San Diego, California, United States (Recruiting)
- UCSF — San Francisco, California, United States (Recruiting)
- Yale — New Haven, Connecticut, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- Ocala Oncology Center — Ocala, Florida, United States (Recruiting)
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- Washington University — Saint Louis, Missouri, United States (Recruiting)
- Rutgers — New Brunswick, New Jersey, United States (Recruiting)
- NYU — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (Recruiting)
- Providence Cancer Institute Franz Clinic — Portland, Oregon, United States (Recruiting)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (Recruiting)
- Intermountain Health — Murray, Utah, United States (Not_yet_recruiting)
- Virginia Commonwealth — Richmond, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Operations
- Email: clinops@asherbio.com
- Phone: 650-410-7588
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.