Cervical Cancer, Esophageal Cancer, Gastric Cancer, Hepatocellular Cancer
Conditions
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.
Interventions
DRUGQ702
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.
BIOLOGICALPembrolizumab
Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle
Sponsors
Qurient Co., Ltd.
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE | Up to approximately 2 years (Each Cycle is 42 Days) |
| Tumor response using RECIST version 1.1 throughout study | Up to approximately 2 years (Each Cycle is 42 Days) |
Secondary
| Measure | Time frame |
|---|---|
| Change in the area under curve (AUC) of Q702 and its primary metabolites | Cycle 1 Day 1 and Day 22 (Each Cycle is 42 Days) |
Countries
South Korea, United States
Outcome results
None listed