Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05775406
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2023-02-10
Brief Title:
Safety and Clinical Activity of KT-253 in Adult Patients With High Grade Myeloid Malignancies Acute Lymphocytic Leukemia Lymphoma Solid Tumors
Sponsor:
Kymera Therapeutics Inc
Organization:
Kymera Therapeutics Inc
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 1 study will evaluate the safety tolerability pharmacokineticspharmacodynamics PKPD and clinical activity of KT-253 in adult patients with relapsed or refractory RR high grade myeloid malignancies acute lymphocytic leukemia ALL RR lymphoma and RR solid tumors The study will identify the pharmacologically optimal doses of KT-253 as the recommended Phase 2 dose RP2D based on all safety PK PD and efficacy data
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None