MC# 22-12 - A Phase 1, First in Human, Dose-Escalation Study of UCT-01-097 in Participants with Advanced Solid Tumors

  • Agent(s): UCT-01-097
  • Disease Type(s): Solid Tumor
  • Phase(s): I
  • Drug Classification(s): Small Molecule, Targeted Therapy
  • 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.


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


  • Dallas, TX - Mary Crowley Cancer Research - Medical City
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Re: MC# 22-12