A Study Evaluating the Safety of Escalating Doses of DLYE5953A in Patients With Refractory Solid Tumors

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: DLYE5953A

• Registration Number: NCT02092792
• Lead Sponsor: Genentech, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-20
• Study Start: 2014-04-01
• Primary Completion: 2017-07-10
• Study Completion: 2017-07-10
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Age >/= 18 years
• ECOG performance status of 0 or 1
• Histologically or cytologically documented advanced or metastatic solid tumors for which established therapy either does not exist or has proven ineffective or intolerable
• Measurable disease by RECIST v1.1 with at least one measurable target lesion

Exclusion Criteria

• Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 4 weeks prior to initiation of DLYE5953A
• Oral kinase inhibitors approved by local regulatory authorities may be used within 2 weeks prior to initiation of DLYE5953A, provided that any clinically relevant drug-related toxicity has completely resolved and prior approval is obtained from the Medical Monitor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose-expansion cohort	DLYE5953A	-
Dose-Escalation Phase	DLYE5953A	-

Primary Outcome Measures

Name	Time	Method
Incidence of dose-limiting toxicities	Days 1 to 21
Incidence of adverse events	Up to 32 months

Secondary Outcome Measures

Name	Time	Method
Objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1	Up to 32 months
Total exposure of the drug, defined as the area under the concentration-time curve (AUC)	Up to 32 months
Duration of objective response	Up to 32 months
Progression-free survival	Up to 32 months
Incidence of anti-DLYE5953A antibodies	Up to 32 months

Trial Locations

Locations (5)

Dana Farber Cancer Inst.; 🇺🇸 Boston, Massachusetts, United States

Karmanos Cancer Center; 🇺🇸 Detroit, Michigan, United States

Yale Cancer Center; Medical Oncology; 🇺🇸 New Haven, Connecticut, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States