This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and PK of escalating doses of DLYE5953A administered to patients with incurable, locally advanced, or metastatic solid malignancy that has progressed on standard therapy. The Phase I study consists of two stages: Stage 1 dose-escalation and Stage 2 expansion in selected patients. In Stage 1, a 3 + 3 dose-escalation design will be used to examine the safety, tolerability, and PK of increasing doses of DLYE5953A. In Stage 2, patients will be enrolled to further characterize the safety, tolerability, and PK of the proposed dose and schedule for future studies.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Escalating doses of DLYE5953A
Administration of DLYE5953A at the recommended phase II dose (RP2D)
University of Colorado Cancer Center
Aurora, Colorado, United States
Yale Cancer Center; Medical Oncology
New Haven, Connecticut, United States
Dana Farber Cancer Inst.
Boston, Massachusetts, United States
Karmanos Cancer Center
Detroit, Michigan, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Incidence of dose-limiting toxicities
Time frame: Days 1 to 21
Incidence of adverse events
Time frame: Up to 32 months
Total exposure of the drug, defined as the area under the concentration-time curve (AUC)
Time frame: Up to 32 months
Incidence of anti-DLYE5953A antibodies
Time frame: Up to 32 months
Objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1
Time frame: Up to 32 months
Duration of objective response
Time frame: Up to 32 months
Progression-free survival
Time frame: Up to 32 months
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