MC# 22-26 - A Phase I/II Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901 Administered via Intravenous Infusion in Adult Patients with Selected Advanced Solid Tumors with a Cohort Expansion at the Recommended Phase 2 Dose
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Agent(s): Q901
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Disease Type(s): Breast, Colorectal, Ovarian, Pancreatic, Prostate, Lung-SCLC
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Phase(s): I, II
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Drug Classification(s): Small Molecule, Targeted Therapy
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Molecular Target(s): CDK7
Mechanism of Action
Q901 is a small molecule inhibitor for CDK7 kinase activity, thereby inhibiting CDK7-mediated signaling. Inhibition of CDK7 may inhibit tumor cell proliferation via inhibiting cell cycle progression, such as CDK1, 2, 4 and 6.
Purpose
In this study, the sponsor and investigators want to learn:
- How much of Q901 can be given with an acceptable level of side effects
- The effects of Q901 (good and bad)
- How much of Q901 is absorbed into the blood and how fast it is removed
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
Location
- Dallas, TX - Mary Crowley Cancer Research - Medical City
