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

NCT04247126 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2023-10-27

No results posted yet for this 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) .

Conditions

Interventions

DRUG

SY-5609

An oral CDK7 Inhibitor

DRUG

Fulvestrant

Estrogen receptor antagonist

DRUG

Gemcitabine

Nucleoside metabolic inhibitor

DRUG

Nab-paclitaxel

Taxane-type chemotherapy

Sponsors & Collaborators

  • Syros Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-23
Primary Completion
2023-01-31
Completion
2023-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04247126 on ClinicalTrials.gov