search
Back to results

Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors

Primary Purpose

Esophageal Cancer, Gastric Cancer, Hepatocellular Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Q702
Pembrolizumab
Sponsored by
Qurient Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
  • Subjects with histologically or cytologically confirmed advanced or metastatic esophageal, gastric/GEJ, hepatocellular and cervical cancers who have progressed on treatment with an anti-PD1 or anti PD-L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other therapies
  • Have measurable disease per RECIST v 1.1. as assessed by local site investigator/radiology
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment or breast-feeding women
  • Concomitant use of strong inhibitors and inducers of CYP1A2, 2J2, 2C19, 2D6, and 3A4/5 within the timeline duration of five half-lives prior to starting study drug and throughout the trial
  • Concomitant use of sensitive substrates of CYP2C9, 2C19, and 3A4 within the timeline duration of five half-lives prior to starting study drug and throughout the trial
  • Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis
  • Has had an allogeneic tissue/solid organ transplant

Sites / Locations

  • University of Southern CaliforniaRecruiting
  • Norton Cancer InstituteRecruiting
  • CHA Bundang Medical CenterRecruiting
  • Asan Medical Center
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose escalation of Q702 in combination with fixed dose of pembrolizumab

Dose expansion of Q702 in combination with fixed dose of pembrolizumab

Arm Description

Give one week on/one week off at selected dose level

Give intravenously once every three week at 200 mg

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE
Tumor response using RECIST version 1.1 throughout study

Secondary Outcome Measures

Change in the area under curve (AUC) of Q702 and its primary metabolites

Full Information

First Posted
May 20, 2022
Last Updated
April 3, 2023
Sponsor
Qurient Co., Ltd.
Collaborators
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT05438420
Brief Title
Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors
Official Title
A Phase 1B/2, Open-label Study of Q702 in Combination With Intravenous Pembrolizumab in Patients With Selected Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
June 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
This study is a phase 1B/2 open-label, study to determine safety and preliminary efficacy of Q702 in combination with pembrolizumab in study subjects with advanced esophageal, gastric/GEJ, hepatocellular, and cervical cancers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Gastric Cancer, Hepatocellular Cancer, Cervical Cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Dose escalation of Q702 in combination with fixed dose of pembrolizumab
Arm Type
Experimental
Arm Description
Give one week on/one week off at selected dose level
Arm Title
Dose expansion of Q702 in combination with fixed dose of pembrolizumab
Arm Type
Experimental
Arm Description
Give intravenously once every three week at 200 mg
Intervention Type
Drug
Intervention Name(s)
Q702
Intervention Description
The study drug Q702 will be administered once daily by mouth on Days 1 through 7, Days 15 through 21 and Days 29 through 35 of every treatment cycle.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
KEYTRUDA®
Intervention Description
Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE
Time Frame
Up to approximately 2 years (Each Cycle is 42 Days)
Title
Tumor response using RECIST version 1.1 throughout study
Time Frame
Up to approximately 2 years (Each Cycle is 42 Days)
Secondary Outcome Measure Information:
Title
Change in the area under curve (AUC) of Q702 and its primary metabolites
Time Frame
Cycle 1 Day 1 and Day 22 (Each Cycle is 42 Days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. Subjects with histologically or cytologically confirmed advanced or metastatic esophageal, gastric/GEJ, hepatocellular and cervical cancers who have progressed on treatment with an anti-PD1 or anti PD-L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other therapies Have measurable disease per RECIST v 1.1. as assessed by local site investigator/radiology Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Life expectancy of at least 3 months Exclusion Criteria: A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment or breast-feeding women Concomitant use of strong inhibitors and inducers of CYP1A2, 2J2, 2C19, 2D6, and 3A4/5 within the timeline duration of five half-lives prior to starting study drug and throughout the trial Concomitant use of sensitive substrates of CYP2C9, 2C19, and 3A4 within the timeline duration of five half-lives prior to starting study drug and throughout the trial Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis Has had an allogeneic tissue/solid organ transplant
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
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
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
CHA Bundang Medical Center
City
Seongnam-si
Country
Korea, Republic of
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
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
See Central Contact
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
See Central Contact

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors

We'll reach out to this number within 24 hrs