Last updated: March 8, 2024
Sponsor: Qurient Co., Ltd.
Overall Status: Active - Recruiting
Phase
1/2
Condition
Cervical Cancer
Gastric Cancer
Pelvic Cancer
Treatment
Q702
Pembrolizumab
Clinical Study ID
NCT05438420
QRNT-008
MK-3475-D35 (KEYNOTE-D35)
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The participant (or legally acceptable representative if applicable) provides writteninformed consent for the trial.
- Subjects with histologically or cytologically confirmed advanced or metastaticesophageal, gastric/GEJ, hepatocellular and cervical cancers who have progressed ontreatment with an anti-PD1 or anti PD-L1 monoclonal antibody (mAb) administered eitheras monotherapy, or in combination with other therapies
- Have measurable disease per RECIST v 1.1. as assessed by local siteinvestigator/radiology
- Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 3 months
Exclusion
Exclusion Criteria:
- A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatmentor breast-feeding women
- Concomitant use of strong inhibitors and inducers of CYP1A2, 2J2, 2C19, 2D6, and 3A4/5within the timeline duration of five half-lives prior to starting study drug andthroughout the trial
- Concomitant use of sensitive substrates of CYP2C9, 2C19, and 3A4 within the timelineduration 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 hada history of radiation pneumonitis
- Has had an allogeneic tissue/solid organ transplant
Study Design
Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Q702
Phase: 1/2
Study Start date:
January 12, 2023
Estimated Completion Date:
June 30, 2026
Connect with a study center
CHA Bundang Medical Center
Seongnam-si,
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul,
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Severance Hospital
Seoul,
Korea, Republic ofActive - Recruiting
University of Southern California
Los Angeles, California 90033
United StatesActive - Recruiting
Norton Cancer Institute
Louisville, Kentucky 40202
United StatesActive - Recruiting
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