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

A PHASE I, OPEN-LABEL STUDY EVALUATING THE SAFETY AND TOLERABILITY OF ESCALATING DOSES OF DLYE5953A IN PATIENTS WITH REFRACTORY SOLID TUMORS

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 Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: DLYE5953A; Drug: DLYE5953A

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale Cancer Center; Medical Oncology
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Inst.
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose-Escalation Phase	Drug: DLYE5953A; Escalating doses of DLYE5953A; Drug: DLYE5953A; Administration of DLYE5953A at the recommended phase II dose (RP2D)
Experimental: Dose-expansion cohort	Drug: DLYE5953A; Escalating doses of DLYE5953A; Drug: DLYE5953A; Administration of DLYE5953A at the recommended phase II dose (RP2D)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of dose-limiting toxicities	Days 1 to 21
Incidence of adverse events	Up to 32 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): July 10, 2017
• Study Completion (Actual): July 10, 2017

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: March 18, 2014
• First Posted (Estimate): March 20, 2014

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: GO29146