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NCT Number: NCT05394103

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a monotherapy and in combination with pembrolizumab

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Cancer Center, Goyang-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 criteria

  • 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

Treatment and study plan

Q901

Drug

The 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)

Drug

KEYTRUDA® (pembrolizumab) will be administered Q6W

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 28 days of cycle 1 (each cycle is 28 days)

Secondary outcomes

  1. Change in the area under curve (AUC) of Q901

    Time frame: Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)

  2. Change in the maximum plasma concentration (Cmax) of Q901

    Time frame: Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)

  3. Change in the time of maximum plasma concentration (Tmax) of Q901

    Time frame: Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)

  4. Tumor response using RECIST version 1.1 throughout study

    Time frame: Baseline and at the end of every even cycle up to approximately 2 years (each cycle is 28 days)

Study contacts

Contact information is provided by the study sponsor or research team.

Qurient Clinical Trial Information

CONTACT

[email protected]

+82-31-8060-1610

Sponsors and collaborators

Lead sponsor

Qurient Co., Ltd.

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901Administered Via Intravenous Infusion as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Selected Advanced Solid Tumors With Cohort Expansions at the Recommended Phase 2 Dose

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 27, 2022
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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