A Phase 1 interventional study of DLYE5953A and DLYE5953A in Neoplasms, sponsored by Genentech, Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-12.
Sponsored by Genentech, Inc. · Phase 1, Interventional, and Treatment
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.
Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: DLYE5953A
Drug: DLYE5953A
Escalating doses of DLYE5953A
Administration of DLYE5953A at the recommended phase II dose (RP2D)
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
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Genentech, Inc.