A Phase I, First in Human, Dose-Escalation Study of UCT-03-008 in Participants withAdvanced Solid Tumors
A Phase I, First in Human, Dose-Escalation Study of UCT-03-008 in Participants withAdvanced Solid Tumors
NCT #
NCT05103046
Condition(s)
Non-Small Cell Lung, Renal Cell Carcinoma, Solid Tumors
Molecular Target(s)
CDK4/6
Drug Classification(s)
Small Molecule, Targeted Therapy
Agents(s)
UCT-03-008
Phase(s)
I
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
- How much of the study drug can be given alone with an acceptable level of side effects
- The effects of the study drug (good and bad) when given alone
- How much of the study drug is absorbed into the blood and how fast it is removed when given alone
- Advanced solid tumor
- Measurable disease, per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Expansion cohort: [KRASwt] Non-small cell lung cancer and Renal Cell Carcinoma
- Adequate organ function
- 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
Received prior treatment with CDK4/6 inhibitor(s)
Location
MCD
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