NCT04247126

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

A Phase 1 Study of SY 5609, an Oral, Selective CDK7 Inhibitor, in Adult Patients With Select Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Syros Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Advanced Solid Tumor
• Breast Cancer
• Small-cell Lung Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	SY-5609	An oral CDK7 Inhibitor
DRUG	Fulvestrant	Estrogen receptor antagonist
DRUG	Gemcitabine	Nucleoside metabolic inhibitor
DRUG	Nab-paclitaxel	Taxane-type chemotherapy

Timeline

• Start date: 2020-01-23
• Primary completion: 2023-01-31
• Completion: 2023-03-30
• First posted: 2020-01-29
• Last updated: 2023-10-27

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study