New treatment for advanced solid tumors using Q901 and pembrolizumab
A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901Administered Via Intravenous Infusion as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Selected Advanced Solid Tumors With Cohort Expansions at the Recommended Phase 2 Dose
PHASE1; PHASE2 · Qurient Co., Ltd. · NCT05394103
This study is testing a new drug called Q901, alone or with pembrolizumab, to see if it can safely help people with advanced solid tumors.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qurient Co., Ltd. (industry) |
| Drugs / interventions | pembrolizumab |
| Locations | 11 sites (Phoenix, Arizona and 10 other locations) |
| Trial ID | NCT05394103 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and potential effectiveness of Q901, a highly selective CDK7 inhibitor, in patients with advanced or metastatic solid tumors. It is a multicenter, open-label study that includes a dose-escalation phase followed by a dose expansion at the recommended phase 2 dose (RP2D). Participants will receive Q901 either as a monotherapy or in combination with pembrolizumab, a known immunotherapy agent. The study aims to assess the drug's pharmacokinetics, pharmacodynamics, and overall tolerability.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced or metastatic ovarian, breast, endometrial, colorectal, small-cell lung, or pancreatic cancer who have progressed after standard-of-care treatments.
Not a fit: Patients with active, uncontrolled infections or significant cardiac issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that have not responded to standard therapies.
How similar studies have performed: Other studies involving CDK inhibitors and immunotherapy combinations have shown promise, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with histologically or cytologically confirmed advanced or metastatic ovarian, CRPC, HR+ HER2- breast, endometrial, colorectal, small-cell lung, or pancreatic cancer, who have progressed following standard-of-care therapy or for whom there is no standard therapy that confers clinical benefit * Measurable disease per RECIST v 1.1 * ECOG performance status 0,1 or 2 * Life expectancy of at least 3 months * Age ≥ 18 years * Signed, written IRB-approved informed consent form Exclusion Criteria: * New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months * Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \>470 msec (females) and \>450 msec (males) * Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy * Active, poorly controlled autoimmune or inflammatory diseases
Where this trial is running
Phoenix, Arizona and 10 other locations
- Mayo Clinic — Phoenix, Arizona, United States (RECRUITING)
- University of Southern California — Los Angeles, California, United States (RECRUITING)
- Mayo Clinic — Jacksonville, Florida, United States (RECRUITING)
- Northwestern University — Chicago, Illinois, United States (RECRUITING)
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
- Atlantic Health System Hospital — Morristown, New Jersey, United States (RECRUITING)
- Mary Crowley Cancer Research — Dallas, Texas, United States (RECRUITING)
- National Cancer Center — Goyang-si, South Korea (RECRUITING)
- CHA University Bundang Medical Center — Seongnam-si, South Korea (RECRUITING)
- Asan Medical Center — Seoul, South Korea (NOT_YET_RECRUITING)
- Severance Hospital — Seoul, South Korea (NOT_YET_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.
Conditions: Advanced Cancer, Metastatic Cancer