for people ages 18 years and up (full criteria)
at UC Davis
study started
completion around



This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and clinical activity of KT-253 in adult patients with relapsed or refractory (R/R) high grade myeloid malignancies, acute lymphocytic leukemia (ALL), R/R lymphoma, and R/R solid tumors. The study will identify the pharmacologically optimal dose(s) of KT-253 as the recommended Phase 2 dose (RP2D), based on all safety, PK, PD, and efficacy data.

Official Title

A Phase 1, 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


This is an open-label Phase 1 (dose escalation) first-in-human study (FIH) of KT-253 in adult patients. This study will be initiated in patients with lymphomas, and solid tumors and then subsequently in patients with advanced high grade myeloid malignancies and ALL. Therefore, the study is comprised of two arms to characterize the safety and tolerability of ascending doses of KT-253 in each arm. Arm A will consist of patients with lymphomas and advanced solid tumors and Arm B will consist of patients with high grade myeloid malignancies and ALL.


Myeloid Malignancies, Acute Lymphocytic Leukemia, Lymphomas, Advanced Solid Tumors, KT-253, MDM2, High Grade MDS/MPN, ALL, AML, Lymphoma, Solid tumor, Neoplasms, Leukemia, Lymphoid Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma


You can join if…

Open to people ages 18 years and up

  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 Tumors and Lymphoma (Arm A) ONLY
    • Histologically or pathologically confirmed solid tumor or lymphoma.
    • Relapsed and/or refractory (R/R) disease to at least two prior standard-of-care treatments or tumors for whom standard therapies are not available.
  3. Advanced high grade myeloid malignancies, and Acute Lymphocytic Leukemia (Arm B) ONLY
    • Primary diagnosis of AML, ALL, High/Very High-risk MDS, MDS/MPN. Must be relapsed/refractory to standard therapies.

You CAN'T join if...

  1. All Participants:
    • Ongoing unstable cardiovascular function.
    • Major surgery requiring general anesthesia within 4 weeks prior to first dose of study drug.
    • History of or active concurrent malignancy unless disease-free for ≥ 2 years.
    • Exposures to anticancer therapy within 2 weeks or 5 half-lives whichever is shorter; or 4 weeks from any biologics/immunotherapies or any investigational therapy prior to the first dose of study drug.
    • Known presence of p53 mutation in tumor tissue
  2. Solid Tumors and Lymphoma (Arm A) ONLY
    • Known active uncontrolled or symptomatic central nervous system (CNS) metastases.
    • Autologous or allogenic hematopoietic stem cell transplant (HSCT) within six months prior to first dose of study drug or participant has progressed within six months from the day of stem cell infusion (for lymphoma participants only).
  3. Advanced high grade myeloid malignancies, and ALL (Arm B) ONLY
    • Active CNS leukemia. Participants with symptoms suggestive of CNS disease will require a lumbar puncture to rule out CNS disease.
    • Prior chemotherapy/radiation (including craniospinal radiation) within 2 weeks prior to the first dose of study drug.
    • Received allogeneic hematopoietic cell transplantation (HCT) <12 weeks prior to first dose or donor lymphocyte infusion (DLI) without conditioning <4 weeks prior to first dose.
    • Received autologous stem cell transplant (ASCT) < 4 weeks prior to first dose or the patient has not recovered from transplant associated toxicities to ≤ grade 1 prior to the first dose of study drug.
    • Received chimeric antigen receptor therapy or other modified T cell therapy <3 weeks prior to the first dose.
    • Patients with signs or symptoms of Grade ≥ 2 acute or chronic graft versus host disease (GVHD) within 2 weeks of enrollment.


  • University of California, Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • HonorHealth Research Institute accepting new patients
    Scottsdale Arizona 85258 United States


accepting new patients
Start Date
Completion Date
Kymera Therapeutics, Inc.
Phase 1 research study
Study Type
Expecting 70 study participants
Last Updated