← Back to Search

CDK7 Inhibitor

SY-5609 for Pancreatic Cancer

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

Study 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.

Eligible Conditions
  • Solid Tumors
  • Pancreatic Cancer
  • Breast Cancer
  • Small Cell Lung Cancer

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Groups 1 and 2: Dose-Limiting Toxicity of SY-5609
Groups 1 and 2: Number of Participants With Treatment Emergent Adverse Events
Groups 3 and 4 (Expansions): Progression Free Survival
+2 more
Secondary outcome measures
Groups 1 and 2: Apparent Clearance of SY-5609
Groups 1 and 2: Apparent Volume of Distribution of SY-5609
Groups 1 and 2: Area Under The Concentration Versus Time Curve of SY-6509
+16 more

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
~3690
Paclitaxel
FDA approved
Gemcitabine
FDA approved
SY-5609
2020
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

Syros PharmaceuticalsLead Sponsor
5 Previous Clinical Trials
923 Total Patients Enrolled

Media Library

SY-5609 (CDK7 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04247126 — Phase 1
Pancreatic Cancer Research Study Groups: Group 1: Single Agent Dose Escalation, Group 2: SY-5609 + Fulvestrant, Group 4: SY-5609 + Gemcitabine + Nab-paclitaxel, Group 3: SY-5609 + Gemcitabine
Pancreatic Cancer Clinical Trial 2023: SY-5609 Highlights & Side Effects. Trial Name: NCT04247126 — Phase 1
SY-5609 (CDK7 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04247126 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any prior precedents to the use of SY-5609 in clinical studies?

"At this time, 133 experiments regarding SY-5609 are in progress. 32 of these trials have reached their third phase and many are being conducted from Shanghai. However, there exists 5794 other research centres conducting studies on this therapeutic option."

Answered by AI

Are there any opportunities to join this scientific experiment at present?

"The research project, which was first published on the 23rd of January 2020 and updated most recently on September 13th 2022, is currently in need of volunteers. This information can be found on clinicaltrials.gov."

Answered by AI

What primary ailments does SY-5609 typically target?

"SY-5609 is a preferred treatment option for prior endocrine therapy, but clinical data indicates it may also be effective in addressing diseases of the breast and mutations to pik3ca genes."

Answered by AI

Has the US Food and Drug Administration approved SY-5609?

"Our experts at Power assigned SY-5609 a rating of 1, as it's still in the initial phase with only limited data available regarding its safety and efficacy."

Answered by AI

Are there numerous health care facilities in the US offering this research project?

"17 medical centres are involved in this medical trial, including University of California Los Angeles (Los Angeles), Duke University (Durham) and Banner MD Anderson Cancer Center (Gilbert). Various other sites will likewise be taking part."

Answered by AI

How many individuals have opted to participate in this experiment?

"This trial requires 160 patients that meet the outlined criteria to partake. These individuals can be enrolled from different medical centres such as University of California Los Angeles and Duke University in Durham, North carolina."

Answered by AI
~20 spots leftby Apr 2025