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SY-5609

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Syros Pharmaceuticals, Inc.|Last Updated: Oct 27, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment105
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04247126A Study of SY 5609, a Selective CDK7 Inhibitor, in Advanced Solid TumorsPHASE1 COMPLETED 105 — — Jan 23, 2020Mar 30, 2023Oct 27, 202316 United States
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Study Endpoints
Primary Endpoints
Groups 1 and 2: Dose-Limiting Toxicity of SY-5609
Up to 28 days after first administration
Groups 1 and 2: Number of Participants With Treatment Emergent Adverse Events
From Baseline up to 30 days after last dose of study drug (up to 1 year)
Groups 3 and 4 (Safety Lead-ins): Number of Participants With Dose-Limiting Toxicity
Up to 28 days after first administration
Groups 3 and 4 (Safety Lead-ins): Number of Participants With TEAEs
From Baseline up to 30 days after last dose of study drug (up to 1 year)
Groups 3 and 4 (Expansions): Progression Free Survival
Up to 1 year
Secondary Endpoints
Groups 1 and 2: Area Under The Concentration Versus Time Curve of SY-6509
Predose, 0.5, 1, 2, 4, 6, 8 hours postdose on Day 1 and 4 or 15 of Cycle 1; 24 hours predose on Day 2 and 5 of Cycle 1; 24 hours predose on Day 1 of Cycle 2, 3 and 4 (Each Cycle=28 days)
Groups 1 and 2: Apparent Clearance of SY-5609
Predose, 0.5, 1, 2, 4, 6, 8 hours postdose on Day 1 and 4 or 15 of Cycle 1; 24 hours predose on Day 2 and 5 of Cycle 1; 24 hours predose on Day 1 of Cycle 2, 3 and 4 (Each Cycle=28 days)
Groups 1 and 2: Apparent Volume of Distribution of SY-5609
Predose, 0.5, 1, 2, 4, 6, 8 hours postdose on Day 1 and 4 or 15 of Cycle 1; 24 hours predose on Day 2 and 5 of Cycle 1; 24 hours predose on Day 1 of Cycle 2, 3 and 4 (Each Cycle=28 days)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1: Single Agent Dose EscalationEXPERIMENTALDose escalation phase to explore maximum tolerated dose of SY-5609 given as a single agent.
Group 2: SY-5609 + FulvestrantEXPERIMENTALParticipants 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 3: SY-5609 + GemcitabineEXPERIMENTALParticipants 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 4: SY-5609 + Gemcitabine + Nab-paclitaxelEXPERIMENTALParticipants 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.
Interventions
NameTypeDescription
SY-5609DRUGAn oral CDK7 Inhibitor
FulvestrantDRUGEstrogen receptor antagonist
GemcitabineDRUGNucleoside metabolic inhibitor
Nab-paclitaxelDRUGTaxane-type chemotherapy
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: 1. Age ≥ 18 years 2. Advanced Solid Tumors for which standard curative or palliative measures do not exist or are no longer effective (Group 1 only). 3. Postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer. Participants must have failed prior...

Countries:United States
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