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CDK7 Inhibitor

A Study of SY 5609, a Selective CDK7 Inhibitor, in Advanced Solid Tumors

Durham, NC

Phase 1

Waitlist Available

Research Sponsored by Syros Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial will be testing a new drug, SY-5609, given alone and in combination with other drugs, to see what effect it has on treating various types of cancer.

See full description

Eligible Conditions

Breast Cancer
Solid Tumors
Pancreatic Cancer
Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Groups 3 and 4 (Expansions): Complete Response Rate

Groups 3 and 4 (Expansions): Duration of Response

Groups 3 and 4 (Expansions): Objective Response Rate

+5 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4: SY-5609 + Gemcitabine + Nab-paclitaxelExperimental Treatment3 Interventions

Participants with PDAC will receive SY-5609 in combination with gemcitabine plus nab-paclitaxel in Safety Lead-in to identify a recommended combination dose for the expansion. The expansion part will assess the safety, tolerability, and preliminary clinical activity of SY-5609 in combination with gemcitabine plus nab-paclitaxel at the recommended combination dose.

Group II: Group 3: SY-5609 + GemcitabineExperimental Treatment2 Interventions

Participants with PDAC will receive SY-5609 in combination with gemcitabine in Safety Lead-in to identify a recommended combination dose for the expansion. The expansion part will assess the safety, tolerability, and preliminary clinical activity of SY-5609 in combination with gemcitabine at the recommended combination dose.

Group III: Group 2: SY-5609 + FulvestrantExperimental Treatment2 Interventions

Participants with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) negative advanced or metastatic breast cancer (BC) that has progressed following prior treatment with a cyclin-dependent kinase (CDK)4/6 inhibitor in combination with hormonal therapy will receive SY-5609 in combination with fulvestrant.

Group IV: Group 1: Single Agent Dose EscalationExperimental Treatment1 Intervention

Dose escalation phase to explore maximum tolerated dose of SY-5609 given as a single agent.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~4160

Paclitaxel

FDA approved