MC# 23-05 - A Phase I, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Intravenously Administered KT-253 in Adult Patients with High Grade Myeloid Malignancies and Acute Lymphocytic Leukemia, Lymphoma and Advanced Solid Tumors
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Agent(s): KT-253
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Disease Type(s): Lymphoma, Solid Tumor
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Phase(s): I
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Drug Classification(s): Targeted Therapy
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Molecular Target(s): MDM2
Mechanism of Action
MDM2 degrader
Purpose
In this study, the sponsor and investigators want to learn:
- How much of KT-253 can be given with an acceptable level of side effects
- The effects of KT-253 (good and bad)
- How much of KT-253 is absorbed into the blood and how fast it is removed
Inclusion Criteria
- Male or female aged ≥ 18 years on the day of signing informed consent.
- Provide signed written informed consent and voluntary consent prior to any mandatory study-specific procedures, sampling, and analyses.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-2.
- Patients of child-bearing potential must use adequate contraception measures to avoid pregnancy for the duration of the study as defined in the protocol
- Resolved acute effects of any prior therapy to baseline severity or Grade ≤1 NCI CTCAE.
- Histologically or pathologically confirmed solid tumor or lymphoma.
- Relapsed and/or refractory disease to at least two prior standard of care treatments or tumors for whom standard therapies are not available.
- Adequate organ function at Screening
Exclusion Criteria
- Ongoing unstable cardiovascular function including history of myocardial infarction within 3 months of planned start of study drug.
- Major surgery within 4 weeks of study entry.
- Infection with hepatitis B (HBV), hepatitis C (HCV), or known history of or current active viral infection with human immunodeficiency virus (HIV).
- History of or active concurrent malignancy unless the patient has been disease-free for ≥ 2 years. Exceptions to the ≥ 2-yrs time limit include treated basal cell or localized squamous cell skin carcinoma, localized prostate cancer, or other localized carcinomas such as carcinoma in situ of cervix, breast, or bladder.
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth.
- Radiation treatment within 4 weeks prior to first dose of study drug.
Location
- Dallas, TX - Mary Crowley Cancer Research - Medical City
