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Q901 for Advanced Solid Tumors

This study is testing a new drug called Q901, alone and in combination with KEYTRUDA® (pembrolizumab), for people with advanced or metastatic (spread to other parts of the body) ovarian, prostate, breast, endometrial, colorectal, small-cell lung, or pancreatic cancer. You might be able to join if your cancer has progressed after standard treatments or if there are no standard treatments that help. The main goal is to see how safe Q901 is and what side effects it causes. Researchers are also looking for signs that the treatment is helping to shrink tumors. The study is currently recruiting participants.

Study design
This is a multicenter, open-label study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll 130 participants.
What's involved
Q901 will be given through an IV for 30 minutes once a week for 4 weeks, then every two weeks. KEYTRUDA® will be given every 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study will assess treatment-related side effects for at least 28 days after the start of each treatment cycle.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05394103

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Qurient Co., Ltd.
~130 participants
Updated 2025-08-17 on ClinicalTrials.gov
What's tested:Q901KEYTRUDA® (pembrolizumab)

At a glance

Recruiting sites
9 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured over 28 days of cycle 1 (each cycle is 28 days)

Conditions

Advanced Cancer
Metastatic Cancer

Explore related trials

Breast CarcinomaColorectal CarcinomaEndometrial CarcinomaLung Small Cell CarcinomaMalignant Ovarian NeoplasmPancreatic CarcinomaProstate CarcinomaSolid Neoplasm

Where it's being run

11 sites across 8 states
South Korea4
Arizona1
California1
Florida1
Illinois1
Minnesota1
New Jersey1
Texas1

Who to contact

Qurient Clinical Trial Information
[email protected]
+82-31-8060-1610
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 that confers clinical benefit
Measurable disease per RECIST v 1.1
ECOG performance status 0,1 or 2
Life expectancy of at least 3 months
Age ≥ 18 years
Signed, written IRB-approved informed consent form

Exclusion

New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months
Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \>470 msec (females) and \>450 msec (males)
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Active, poorly controlled autoimmune or inflammatory diseases

What this trial measures

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.028 days of cycle 1 (each cycle is 28 days)