Combining Q702 with Pembrolizumab for Advanced Solid Tumors
A Phase 1B/2, Open-label Study of Q702 in Combination With Intravenous Pembrolizumab in Patients With Selected Advanced Solid Tumors
This study is testing if a new cancer drug called Q702, when combined with pembrolizumab, can help people with advanced esophageal, gastric, liver, and cervical cancers who haven't responded to other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qurient Co., Ltd. Industry-sponsored |
| Drugs / interventions | radiation, pembrolizumab |
| Locations | 7 sites (Los Angeles, California and 6 other locations) |
| Trial ID | NCT05438420 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and preliminary efficacy of Q702, a selective tyrosine kinase inhibitor, in combination with pembrolizumab, an immune checkpoint inhibitor, for patients with advanced esophageal, gastric, hepatocellular, and cervical cancers. It is an open-label phase 1B/2 trial targeting individuals who have previously progressed on anti-PD1 or anti-PD-L1 therapies. Participants will be monitored for measurable disease and overall health status throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced or metastatic esophageal, gastric, hepatocellular, or cervical cancers who have previously received anti-PD1 or anti-PD-L1 therapies.
Not a fit: Patients who are currently pregnant, breastfeeding, or using certain strong inhibitors or inducers of specific cytochrome P450 enzymes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could provide a new therapeutic option for patients with advanced solid tumors that have not responded to existing treatments.
How similar studies have performed: While the combination of targeted therapies and immune checkpoint inhibitors is being explored in various studies, this specific combination of Q702 and pembrolizumab is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California and 6 other locations
- University of Southern California — Los Angeles, California, United States (Recruiting)
- Norton Cancer Institute — Louisville, Kentucky, United States (Recruiting)
- CHA Bundang Medical Center — Seongnam-si, Korea, Republic of (Recruiting)
- Asan Medical Center — Seoul, Korea, Republic of (Not_yet_recruiting)
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
- Severance Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Qurient Clinical Trial Information
- Email: clinicaltrial_info@qurient.com
- Phone: +82-31-8060-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.