Clinical trial NCT05438420: 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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Esophageal Cancer
Gastric Cancer
Hepatocellular Cancer
Cervical Cancer
Lead sponsor: Qurient Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-06-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE
timeFrame: Up to approximately 2 years (Each Cycle is 42 Days)
measure: Tumor response using RECIST version 1.1 throughout study
timeFrame: Up to approximately 2 years (Each Cycle is 42 Days)
Secondary outcomes:
measure: Change in the area under curve (AUC) of Q702 and its primary metabolites
timeFrame: Cycle 1 Day 1 and Day 22 (Each Cycle is 42 Days)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: