Safety and Clinical Activity of KT-253 in Adult Patients with High Grade Myeloid Malignancies, Acute Lymphocytic Leukemia, Lymphoma, Solid Tumors
NCT05775406 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2025-01-27
Summary
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, myelofibrosis, and R/R solid tumors. The study will identify the pharmacologically optimal dose(s) (MTD) of KT-253 as the recommended Phase 2 dose (RP2D), based on all safety, PK, PD, and efficacy data.
Conditions
- Myeloid Malignancies
- Acute Lymphocytic Leukemia
- Lymphomas
- Advanced Solid Tumors
Interventions
- DRUG
-
KT-253
KT-253 will be administered intravenously per the defined protocol frequency and dose level.
Sponsors & Collaborators
-
Kymera Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Ashwin Gollerkeri, MD · Kymera Therapeutics, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-15
- Primary Completion
- 2024-12-18
- Completion
- 2024-12-18
- FDA Drug
- Yes
Countries
- United States
Study Locations
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