MC# 22-13 - A Phase I, First in Human, Dose-Escalation Study of UCT-03-008 in Participants with Advanced Solid Tumors
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Agent(s): UCT-03-008
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Disease Type(s): Solid Tumor
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Phase(s): I
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Drug Classification(s): Small Molecule, Targeted Therapy
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Molecular Target(s): CDK4/6
Mechanism of Action
UCT-03-008, CDK4/6 inhibitor, inhibits protein kinase from working and therefore, potentially stopping cancer cells to grow. Protein kinases are enzymes that are involved in the signaling pathway of cells that tell some cells to grow or to stop growing in the body.
Purpose
In this study, the sponsor and investigators want to learn:
- How much of UCT-03-008 can be given with an acceptable level of side effects
- The effects of UCT-03-008 (good and bad)
- How much of UCT-03-008 is absorbed into the blood and how fast it is removed
Inclusion Criteria
- Advanced solid tumor
- Measurable disease, per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function
Exclusion Criteria
- Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
- Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of UCT-03-008
- Progressive or symptomatic brain metastases
- Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
- History of significant cardiac disease
- History or current evidence/risk of retinopathy
- History of myelodysplastic syndrome (MDS) or AML
- History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
- If female, is pregnant or breastfeeding
Location
- Dallas, TX - Mary Crowley Cancer Research - Medical City
