NCT05394103 Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
| NCT ID | NCT05394103 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Qurient Co., Ltd. |
| Condition | Advanced Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2022-08-30 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 130 participants in total. It began in 2022-08-30 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 monotherapy and in combination with pembrolizumab
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05394103 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05394103 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05394103 currently recruiting?
Yes, NCT05394103 is actively recruiting participants. Contact the research team at clinicaltrial_info@qurient.com for enrollment information.
Where is the NCT05394103 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, Jacksonville, United States, Chicago, United States and 10 additional locations.
Who is sponsoring the NCT05394103 clinical trial?
NCT05394103 is sponsored by Qurient Co., Ltd.. The trial plans to enroll 130 participants.
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