RWF_SGNS40-001

A Phase 1, Open-label, Dose-escalation Study of SEA-CD40 in Adult Patients With Advanced Malignancies

This study will examine the safety profile of SEA-CD40. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens may also be evaluated to see if more SEA-CD40 can be given within a treatment cycle while maintaining an acceptable safety profile. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.

Inclusion Criteria:

* Histologically confirmed advanced metastatic or unresectable solid malignancy

* Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy

* Representative baseline tumor tissue sample is available

Exclusion Criteria:

* Prior chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies) within 2 weeks

* Prior immune-checkpoint inhibitors within 4 weeks

* Prior monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies within 12 weeks; or 2 weeks if patient experienced disease progression on the prior treatment
Phase I
NCT02376699
Oncology
Multiple Tumor Types
Brendan Curti, M.D.
Seattle Genetics Inc.
Kim Sutcliffe
  • Oncology and Hematology Care Eastside