TL-895 and KRT-232 Study in Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT04669067|
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : September 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: TL-895 Drug: KRT-232||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined With KRT-232 in Patients With Relapsed/Refractory (R/R) FLT3+ Acute Myeloid Leukemia (AML)|
|Actual Study Start Date :||March 31, 2021|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2024|
Experimental: TL-895 combined with KRT-232
TL-895 will be administered orally, twice a day (BID) continuously starting on Day 1 in a 28-day cycle.
KRT-232 will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle.
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.
- Primary Objective, Phase 1b: To determine the MTD/MAD and recommended Phase 2 dose (RP2D) of TL-895 in combination with KRT-232 [ Time Frame: 13 months ]Dose limiting toxicities will be used to established the MTD/MAD of TL-895 combined with KRT-232. The Safety Review Committee (SRC) will determine the RP2D based on safety data of the combination of TL-895 and KRT-232.
- Primary Objective, Phase 2: To determine the rates of complete remission (CR) and complete remission with partial hematologic recovery (CRh) [ Time Frame: 41 months ]The proportion of subjects who achieved CR or CRh as their best response based on the Modified 2017 European LeukemiaNet (ELN) Response Criteria (Appendix 4).
- Key Secondary Objective: To characterize the peak plasma concentration (Cmax) of TL-895 and KRT-232 [ Time Frame: 13 months ]Cmax of TL-895 and KRT-232
- Key Secondary Objective: To characterize the area under the plasma concentration versus time curve (AUC) of TL-895 and KRT-232 [ Time Frame: 13 months ]AUC of TL-895 and KRT-232
- Key Secondary Objective: To characterize the time to Cmax (Tmax) of TL-895 and KRT-232 [ Time Frame: 13 months ]Tmax of TL-895 and KRT-232
- Key Secondary Objective: To determine the overall response rate (ORR) [ Time Frame: 41 months ]The proportion of subjects who achieve PR or better.
- Key Secondary Objective: To determine the duration of CR/CRh response (DOR) [ Time Frame: 41 months ]Median DOR (Kaplan-Meier estimate) defined as the time from first observation of CR/CRh to relapse or death from any cause, whichever occurs first. Subjects with MLFS by bone marrow biopsy performed earlier in the course of therapy who convert to CR or CRh do not require a separate bone marrow aspirate at the time of CR or CRh to document this.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669067
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