Treatment Study for Patients with Advanced Malignancies
The purpose of this study is to test the safety and tolerability of SEA-CD40 in adult patients with advanced malignancies and to collect data.
In order to participate you must meet the following criteria:
Have a measurable disease, defined as:
- Solid tumors: At least 1 tumor lesion ≥10 mm in the longest diameter or a lymph node ≥15 mm in short-axis measurement assessed by computed tomography (CT) scan (RECIST v1.1). For dose levels at which single-patient cohorts are planned, measurable disease is not required
- Lymphomas: Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and measurable disease of ≥15 mm in the greatest transverse diameter by CT, as assessed by the site radiologist.
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Have completed prior therapy within an acceptable timeframe before the first dose of study drug as follows:
- Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks
- Immune-checkpoint inhibitors (i.e., anti-PD-1, anti-PD-L1, or anti-CTLA-4): 4 weeks
- Other monoclonal antibodies, antibody-drug conjugates, or radioimmunoconjugates: 4 weeks (2 weeks with documented disease progression)
- T-cell or other cell-based therapies: 12 weeks (2 weeks with documented disease progression)
- Have recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration.
You will be excluded from the study if any of the following criteria apply to you:
- Have a documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III–IV within 6 months prior to your first dose of SEA-CD40.
- Have any serious health condition, which, in the opinion of the investigator, would place the patient at undue risk from the study, including uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 3 months) or neurological disorder (e.g., seizure disorder active within 3 months).
Have recent or ongoing serious infection, including:
- Any active Grade 3 or higher (per the NCI CTCAE, version 4.03) viral, bacterial, or fungal infection within 2 weeks of the first dose of study drug. Routine antimicrobial prophylaxis is permitted.
- Known seropositivity for or active infection by human immunodeficiency virus (HIV).
- Known positive for hepatitis B by surface antigen expression, or any other positive test for hepatitis B virus indicating acute or chronic infection.
- Known active hepatitis C infection (positive by serology and confirmed by polymerase chain reaction) or on antiviral therapy for hepatitis C within 6 months of first dose of study drug.
- Have autoimmune or auto-inflammatory ocular disease, such as uveitis, iritis, scleritis, or optic neuritis, active within the previous 6 months, which may be exacerbated by the known mechanism of action of SEA-CD40.
This is a partial list of inclusion and exclusion criteria.