Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 1

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

NCT04247126 · View on ClinicalTrials.gov ↗

Study Summary

The study consists of 2 parts. Part 1 is dose escalation and will first administer SY-5609 alone to participants with select advanced solid tumors and then in combination with fulvestrant to participants with HR positive, HER2-negative breast cancer. Part 2 is a dose expansion and will first administer SY-5609 in combination with gemcitabine and then SY-5609 in combination with gemcitabine and nab-paclitaxel in participants with pancreatic ductal adenocarcinoma (PDAC) .

Interventions

  • DRUG Fulvestrant
  • DRUG Gemcitabine
  • DRUG Nab-paclitaxel
  • DRUG SY-5609

Study Locations (16)

California

  • Cedars-Sinai Medical Center — Los Angeles
  • University of California Los Angeles — Los Angeles

Massachusetts

  • Massachusetts General Hospital — Boston
  • Dana Farber Cancer Institute — Boston

Michigan

  • University of Michigan — Ann Arbor
  • START Midwest, LLC — Grand Rapids

Arizona

  • Banner MD Anderson Cancer Center — Gilbert

Florida

  • Orlando Health Cancer Institute — Orlando

Georgia

  • Emory University — Atlanta

Iowa

  • The University of Iowa — Iowa City

Maryland

  • Johns Hopkins University — Baltimore

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2020-01-23
Est. Completion 2023-03-30
Phase Phase 1

Sponsor

Syros Pharmaceuticals

1 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04247126

The ClinicalTrials.gov registry entry for NCT04247126 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Syros Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions — of which Fulvestrant is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04247126 reports 16 study locations spanning 13 distinct geographic areas — top geographies include California, Massachusetts, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04247126 about?

NCT04247126 is a clinical study titled "A Study of SY 5609, a Selective CDK7 Inhibitor, in Advanced Solid Tumors". The study consists of 2 parts. Part 1 is dose escalation and will first administer SY-5609 alone to participants with select advanced solid tumors and then in combination with fulvestrant to participants with HR positive, HER2-negative breast cancer. Part 2 is a dose expansion and will first adminis...

What is the current status of trial NCT04247126?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2020-01-23. Estimated completion is 2023-03-30.

What conditions does trial NCT04247126 study?

This clinical trial studies the following conditions: Breast Cancer, Pancreatic Cancer, Advanced Solid Tumor, Small-cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04247126?

The interventions under investigation include: Fulvestrant (DRUG), Gemcitabine (DRUG), Nab-paclitaxel (DRUG), SY-5609 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04247126?

This trial is sponsored by Syros Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04247126 being conducted?

This trial has 16 study locations across Arizona, California, Florida, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial