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KT-253 · 1 trial · 4 indications
Adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
MTD and RP2D will be determined in patients with R/R high grade myeloid malignancies, ALL, and separately, in patients with lymphomas and advanced solid tumors
| Arm | Type | Description |
|---|---|---|
| Phase 1 Dose Escalation Arm A in patients with R/R Solid Tumors and Lymphomas | EXPERIMENTAL | KT-253 dosed intravenous (IV) once every three weeks in 21-day cycles |
| Phase 1 Dose Escalation Arm B in patients with R/R High Grade Myeloid Malignancies and ALL | EXPERIMENTAL | KT-253 dosed IV once every three weeks in 21-day cycles |
| Name | Type | Description |
|---|---|---|
| KT-253 | DRUG | KT-253 will be administered intravenously per the defined protocol frequency and dose level. |
Inclusion Criteria: 1. All Participants: * Eastern Cooperative Oncology Group performance status: 0-2. * Resolved acute effects of any prior therapy except for alopecia to baseline severity or Grade ≤1 NCI CTCAE and Grade ≤2 neuropathy * Adequate organ function at screening 2. Solid Tumor...
KT-253 is an investigational small molecule being studied in adults with high grade myeloid malignancies, including acute lymphocytic leukemia, lymphoma, and advanced solid tumors. It is not approved for any indication and remains in clinical development. Kymera Therapeutics holds an orphan drug designation for KT-253.
KT-253 targets MDM2, a protein that regulates the tumor suppressor p53. By acting on MDM2, the drug is designed to affect p53 pathway signaling in cancer cells. This targeted mechanism distinguishes it from conventional cytotoxic chemotherapy and supports its study across both blood cancers and solid tumors.
KT-253 is developed by Kymera Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker KYMR. Kymera is responsible for the clinical development program, including the Phase 1 study conducted in the United States.
KT-253 is in Phase 1 clinical development. The single Phase 1 trial, NCT05775406, has been completed and enrolled 52 adult patients. The drug is investigational and has not received FDA approval for any indication.
KT-253 has been evaluated in one Phase 1 trial, NCT05775406, titled Safety and Clinical Activity of KT-253 in Adult Patients with High Grade Myeloid Malignancies, Acute Lymphocytic Leukemia, Lymphoma, Solid Tumors. The study enrolled 52 adults in the United States and is now completed.
KT-253 has received an orphan drug designation from the FDA. This designation is granted for investigational therapies intended to treat rare diseases or conditions. It does not constitute approval, and KT-253 remains an investigational agent in Phase 1 development.