Phase 1 / Phase 2: testing Mocaciclib (Q901) for Advanced Cancer
Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a this drug alone and in combination with pembrolizumab
Official registry: https://clinicaltrials.gov/study/NCT05394103 · Qurient Co., Ltd. · enrollment listed as 130
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Mocaciclib (Q901), KEYTRUDA® (pembrolizumab), or Fulvestrant. The registry lists allocation as randomized. Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a this drug alone and in combination with pembrolizumab
They plan to enroll about 130 people at 14 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: Mocaciclib (Q901), KEYTRUDA® (pembrolizumab), Fulvestrant
Primary outcome (registry wording): Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Measurable disease per RECIST v 1.1
- how well you can do daily activities (ECOG score) 0,1 or 2
- Life expectancy of at least 3 months
Who the registry excludes
- 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
Public study contact (from the registry)
Qurient Clinical Trial Information
clinicaltrial_info@qurient.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
14 listed- Mayo Clinic — Phoenix, Arizona (recruiting)
- University of Southern California — Los Angeles, California (recruiting)
- Mayo Clinic — Jacksonville, Florida (recruiting)
- Northwestern University — Chicago, Illinois (recruiting)
- Mayo Clinic — Rochester, Minnesota (recruiting)
- Atlantic Health System Hospital — Morristown, New Jersey (recruiting)
- Mary Crowley Cancer Research — Dallas, Texas (recruiting)
+ 7 sites outside the US on the same record
FAQ about this NCT record
Is NCT05394103 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05394103?
Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05394103?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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