A Study of SY-1365 in Adult Patients With Advanced Solid Tumors

PHASE1TerminatedINTERVENTIONAL
Enrollment

107

Participants

Timeline

Start Date

May 12, 2017

Primary Completion Date

May 15, 2020

Study Completion Date

June 24, 2020

Conditions
Advanced Solid TumorsOvarian CancerBreast Cancer
Interventions
DRUG

SY-1365 (Part 1)

"Two dosing schedules will be evaluated in dose escalation and a dose(s)/schedule(s) will be determined for Part 2:~* Twice weekly: SY-1365 will be administered by intravenous infusion over 1 or 2 hours twice a week for 3 weeks of each 4 week (28 day) cycle.~* Weekly: SY-1365 will be administered by intravenous infusion over 1 or 2 hours once a week for 3 weeks of each 4 week (28 day) cycle."

DRUG

Carboplatin

Carboplatin will be administered on Day 1 of each 3 week (21-day) cycle (Part 2 only)

DRUG

Fulvestrant

Fulvestrant will be administered as an intramuscular (IM) dose of 500 mg every 2 weeks for the first 3 doses on Day 1 and Day 15 of the first 28-day cycle (Cycle 1), and on Day 1 of the second 28 day cycle (Cycle 2), and monthly thereafter starting on Day 1 of Cycle 3 (Part 2 only)

DRUG

SY-1365 (Cohort 2)

In combination with carboplatin, SY-1365 will be administered by intravenous infusion over 1 or 2 hours for 2 weeks of each 3 week (21-day) cycle (Part 2 only)

DRUG

SY-1365 (Cohort 5)

In combination with fulvestrant, SY-1365 will be administered by intravenous infusion over 1 or 2 hours once a week for 3 weeks of each 4 week (28-day) cycle (Part 2 only)

DRUG

SY-1365 (Part 2 Single Agent)

SY-1365 will be administered by intravenous infusion over 1 or 2 hours twice a week for 3 weeks of each 4 week (28 day) cycle

Trial Locations (20)

10032

Columbia University Medical Center, New York

35233

University of Alabama at Birmingham, Birmingham

37203

Tennessee Oncology, Nashville

60637

University of Chicago Medical Center, Chicago

73104

Stephenson Cancer Center, Oklahoma City

75390

University of Texas Southwestern Medical Center, Dallas

76104

Texas Oncology, Fort Worth

78229

South Texas Accelerated Research Therapeutics, San Antonio

78705

Texas Oncology, Austin

85258

Honor Health Research Institute, Scottsdale

94118

Palo Alto Medical Foundation Group, San Francisco

97401

Willamette Valley Cancer Institute and Research Center, Eugene

02114

Massachusetts General Hospital, Boston

02215

Dana Farber Cancer Institute, Boston

02905

Women and Infants Hospital of Rhode Island, Providence

L8V 1C3

Hamilton Health Sciences, Hamilton

H4A 3J1

McGill University Health Center, Montreal

69373 Lyon Cedex

Centre Léon Bérard, Lyon

44805 Saint Herblain Cedex

Institut de Cancérologie de l'Ouest, Saint-Herblain

94805 Villejuif Cedex

Institut Gustave Roussy, Villejuif

Sponsors
All Listed Sponsors
lead

Syros Pharmaceuticals

INDUSTRY