MC# 22-12 - A Phase 1, First in Human, Dose-Escalation Study of UCT-01-097 in Participants with Advanced Solid Tumors
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Agent(s): UCT-01-097
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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): ERK1/2
Mechanism of Action
UCT-01-097 may target, bind to and inhibit the activity of one or more kinases that play a key role in tumor cell proliferation.
Purpose
In this study, the sponsor and investigators want to learn:
- How much of UCT-01-097 can be given with an acceptable level of side effects
- The effects of UCT-01-097 (good and bad)
- How much of UCT-01-097 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-01-097
- Progressive or symptomatic brain metastases
- Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
- History of phosphate or calcium disorder
- 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
