A Phase 1 Study of SY 5609, an Oral, Selective CDK7 Inhibitor, in Adult Patients With Select Advanced Solid Tumors
A Phase 1 Study of SY 5609, an Oral, Selective CDK7 Inhibitor, in Adult Patients With Select Advanced Solid Tumors
-
Clinical Trial Information
Trial Contact: Grofsik, Kiera; Donaldson, Karin M; Frankos, Marie
Trial Phone: 321.841.6626 ; 321.841.9821 ; 321.841.7303
-
IRB No: 21.112.07
Protocol Abbrev: SY-5609-101
Principal Investigator: Sajeve Samuel Thomas, MD
Phase: Drug: Phase I
Age Group: Adult
Secondary Protocol No: SY-5609-101
Treatment: SY-5609 Fulvestrant
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT04247126
-
Objective
Primary Objectives:
• Determine the safety, tolerability, and MTD of SY-5609 as a single agent (Group 1)
Secondary Objectives
• Characterize the PK of SY-5609
• Characterize the safety and tolerability of SY-5609 in combination with fulvestrant (Group 2)
Exploratory Objectives
• Evaluate the pharmacodynamic effects of SY-5609 in blood and tissues
• Evaluate the preliminary antitumor activity of SY-5609 in patients with select advanced solid tumor
malignancies
SY-5609 Dated 10 December 2020
Clinical Study Protocol SY-5609-101 Amendment 5.0
Syros Pharmaceuticals, Inc. Confidential Page 8 of 78
• Evaluate the preliminary antitumor activity of SY-5609 + fulvestrant in patients with HR-positive,
HER2-negative advanced or metastatic breast cancer
• Identify candidate biomarkers predictive of response to SY-5609 -
Key Eligibility
Patients may be eligible for inclusion in the study if they meet the following criteria:
1. Age ≥ 18 years
2. Diseases for which standard curative or palliative measures do not exist or are no longer effective, including:
Patients Enrolled into Single-Agent SY-5609 Dose Escalation (Group 1)
• Histologically confirmed metastatic or unresectable breast, ovarian (including fallopian tube and primary peritoneal), lung, colorectal, and pancreatic (pancreatic ductal adenocarcinoma) cancers, or
• Any metastatic or unresectable solid tumor histology with evidence of deregulated RB cell cycle control (mutation or homozygous deletion of RB1, CDKN1A, or CDKN2A, or focal high-level amplification of CCNE1, CCND1, CCND2, CDK4, or CDK6) based on available molecular test results and after Sponsor review to confirm eligibility
