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

Summary

This study consists of two parts. Part 1 is a dose-escalation/safety evaluation to provisionally identify a dose and regimen of SY-1365 for further evaluation in Part 2.

Following the identification of a recommended dose and regimen from Part 1, the study entered Part 2 to further evaluate safety and the antitumor activity of SY-1365 in patients with select solid tumors, and to confirm target engagement and downstream pathway impact in patients with any solid tumor histology.

Conditions

• Advanced Solid Tumors
• Ovarian Cancer
• Breast 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

Sponsors & Collaborators

• Syros Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Kate Madigan, MD · Syros Pharmaceuticals

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-12

Primary Completion

2020-05-15

Completion

2020-06-24

FDA Drug

Yes

Countries

• United States
• Canada
• France

Study Locations