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Q901

Phase 1

Advanced Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Aug 17, 2025

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 Enrollment130
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05394103Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid TumorsPHASE1 RECRUITING 130Aug 30, 2022Aug 30, 2026Aug 17, 202511 United States, South Korea
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Study Endpoints
Primary Endpoints
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
28 days of cycle 1 (each cycle is 28 days)
Secondary Endpoints
Change in the area under curve (AUC) of Q901
Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)
Change in the maximum plasma concentration (Cmax) of Q901
Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)
Change in the time of maximum plasma concentration (Tmax) of Q901
Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose escalation (Q901)EXPERIMENTAL -
Q901 Single-Agent Expansion CohortsEXPERIMENTAL -
Q901 + KEYTRUDA® (pembrolizumab) CohortsEXPERIMENTAL -
Interventions
NameTypeDescription
Q901DRUGThe study drug Q901 will be administered by IV infusion over a 30-minute period using a QW dosing schedule for 4 weeks, followed by a Q2W interval dosing schedule thereafter
KEYTRUDA® (pembrolizumab)DRUGKEYTRUDA® (pembrolizumab) will be administered Q6W
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Participants with histologically or cytologically confirmed advanced or metastatic ovarian, CRPC, HR+ HER2- breast, endometrial, colorectal, small-cell lung, or pancreatic cancer, who have progressed following standard-of-care therapy or for whom there is no standard therapy t...

Countries:United StatesSouth Korea
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05394103studyFirstPostDate: changed