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Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Primary Purpose

Advanced Cancer, Metastatic Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Q901
Pembrolizumab
Sponsored by
Qurient Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo ClinicRecruiting
  • University of Southern CaliforniaRecruiting
  • Mayo ClinicRecruiting
  • Northwestern UniversityRecruiting
  • Mayo ClinicRecruiting
  • Atlantic Health System HospitalRecruiting
  • Mary Crowley Cancer ResearchRecruiting
  • Asan Medical Center
  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dose escalation (Q901)

Q901 Single-Agent Expansion Cohorts

Q901 + Pembrolizumab Cohorts

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in the area under curve (AUC) of Q901
Change in the maximum plasma concentration (Cmax) of Q901
Change in the time of maximum plasma concentration (Tmax) of Q901
Tumor response using RECIST version 1.1 throughout study

Full Information

First Posted
May 19, 2022
Last Updated
June 21, 2023
Sponsor
Qurient Co., Ltd.
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05394103
Brief Title
Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
August 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qurient Co., Ltd.
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 as a monotherapy and in combination with pembrolizumab

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Metastatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose escalation (Q901)
Arm Type
Experimental
Arm Title
Q901 Single-Agent Expansion Cohorts
Arm Type
Experimental
Arm Title
Q901 + Pembrolizumab Cohorts
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Q901
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Pembrolizumab will be administered Q6W
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qurient Clinical Trial Information
Phone
+82-31-8060-1610
Email
clinicaltrial_info@qurient.com
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
See Central Contact
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
See Central Contact
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
See Central Contact
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
See Central Contact
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
See Central Contact
Facility Name
Atlantic Health System Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
See Central Contact
Facility Name
Mary Crowley Cancer Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
See Central Contact
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
See Central Contact
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
See Central Contact

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

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