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Q901

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment130

FDA Designations

No designations recorded

Clinical trial landscape

Q901 · 1 trial · 2 indications

Phase 1 1
NCT05394103Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid TumorsAdvanced Cancer
RECRUITING130 Analytics
PHASE1RECRUITING
Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
Advanced CancerUnlock trial analytics

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 to 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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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about Q901

What is Q901 used for in Advanced Cancer?

Q901 is an investigational small molecule being studied for the treatment of advanced and metastatic cancer. It is currently in Phase 1 clinical development, with a trial enrolling patients with advanced solid tumors. The drug is being evaluated as a potential therapy for these conditions, though it is not yet approved.

What does Q901 target?

Q901 is a highly selective CDK7 inhibitor. CDK7 is a cyclin-dependent kinase involved in cell cycle regulation and transcription. By inhibiting CDK7, Q901 aims to disrupt cancer cell proliferation. This targeted mechanism is being investigated in a Phase 1 trial for advanced solid tumors.

Who makes Q901?

Q901 is being developed by Merck & Company, Inc., a global pharmaceutical company. Merck is conducting clinical trials to evaluate the safety and efficacy of Q901 in patients with advanced cancer. The company is listed on the stock exchange under the ticker symbol MRK.

What phase is Q901 in?

Q901 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial is currently recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.

What clinical trials is Q901 in?

Q901 is being studied in a Phase 1 clinical trial with the identifier NCT05394103. The trial is titled 'Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors' and is recruiting 130 participants in the United States and South Korea. The study is open to adults aged 18 and older.

Is Q901 the same as other CDK7 inhibitors?

Q901 is a specific investigational CDK7 inhibitor developed by Merck. While it shares a target with other CDK7 inhibitors, Q901 is a distinct compound with its own chemical structure and clinical development program. No alternative names for Q901 have been reported.