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Trial record 1 of 1 for:    Q901
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Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05394103
Recruitment Status : Recruiting
First Posted : May 27, 2022
Last Update Posted : September 7, 2022
Sponsor:
Information provided by (Responsible Party):
Qurient Co., Ltd.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Advanced Cancer Metastatic Cancer Drug: Q901 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901 Administered Via Intravenous Infusion in Adult Patients With Selected Advanced Solid Tumors With a Cohort Expansion at the Recommended Phase 2 Dose
Actual Study Start Date : August 30, 2022
Estimated Primary Completion Date : December 30, 2025
Estimated Study Completion Date : August 30, 2026

Arm Intervention/treatment
Experimental: Dose escalation (Q901) Drug: Q901
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




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05394103


Contacts
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Contact: Qurient Clinical Trial Information +82-31-8060-1610 clinicaltrial_info@qurient.com

Locations
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United States, Arizona
Mayo Clinic Not yet recruiting
Phoenix, Arizona, United States, 85054
Contact: See Central Contact         
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: See Central Contact         
United States, Florida
Mayo Clinic Not yet recruiting
Jacksonville, Florida, United States, 32224
Contact: See Central Contact         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: See Central Contact         
United States, New Jersey
Atlantic Health System Hospital Not yet recruiting
Morristown, New Jersey, United States, 07960
Contact: See Central Contact         
United States, Texas
Mary Crowley Cancer Research Not yet recruiting
Dallas, Texas, United States, 75230
Contact: See Central Contact         
Sponsors and Collaborators
Qurient Co., Ltd.
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Responsible Party: Qurient Co., Ltd.
ClinicalTrials.gov Identifier: NCT05394103    
Other Study ID Numbers: QRNT-009
First Posted: May 27, 2022    Key Record Dates
Last Update Posted: September 7, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes