The goal of this clinical trial is * To assess the safety and tolerability of PEP07 administered orally as a single dose and at escalating dose levels, and, to determine the dose-limiting toxicity (DLT) of study treatment in patients with Acute Myeloid Leukemia (AML) and Mantle Cell Lymphoma (MCL). * To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of PEP07 monotherapy. Participants will receive PEP07 administered orally once daily (QD) for 2 consecutive days and 5 days off, every week for 4 weeks until disease progression, intolerable toxicity, confirmed pregnancy, death, consent withdrawal, HSCT or other anti-cancer treatment is required, or the Sponsor ends the study, whichever occurs first.
This is a Phase 1b, open-label, multi-center study recruiting patients with R/R AML and MCL. The study will utilize an Accelerated Titration Design in the lower dose levels followed by a traditional 3+3 dose escalation design at higher dose levels until RP2D is determined. The starting dose will be 40 mg. All potential study candidates will provide informed consent and will undergo screening procedures before participating in the study. After a screening period of up to 28 days, qualified patients will be enrolled to receive their assigned dose regimen of PEP07 monotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
PEP07 is a selective Chk1 inhibitor maleate drug which is supplied as a hard gelatin capsule. PEP07 will be provided as 20 mg and 150 mg strength capsules to be administrated orally. Patients allocated to different dose levels of PEP07 monotherapy will receive either 20 mg or 150 mg oral capsules for 2 consecutive days followed by 5 days treatment off (2-on/5-off) schedule every week, 4 weeks as a treatment cycle.
Monash Medical Centre
Clayton, Victoria, Australia
RECRUITINGKaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
RECRUITINGChina Medical University Hospital
Taichung, Taiwan
RECRUITINGChang Gung Memorial Hospital- Linkou
Taipei, Taiwan
RECRUITINGNational Taiwan University Hospital
Taipei, Taiwan
RECRUITINGTo assess the safety and tolerability of PEP07 administered orally as a single dose and at escalating dose levels, and, to determine the dose-limiting toxicity (DLT) of study treatment in patients with AML and MCL.
to find out the DLT
Time frame: 4 weeks after first dosing
To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of PEP07 monotherapy.
to find out the MTD
Time frame: 4 weeks after first dosing
To assess the AUC from time zero to infinity (AUC0-inf) of single and multiple oral PEP07 as a monotherapy.
to know the PK profile
Time frame: 6 months
To assess the Time to maximum (peak) plasma concentration (Tmax) of single and multiple oral PEP07 as a monotherapy.
to know the PK profile
Time frame: 6 months
To assess the apparent half-life (t1/2) of single and multiple oral PEP07 as a monotherapy.
to know the PK profile
Time frame: 6 months
To assess the Maximum observed concentration (Cmax) of single and multiple oral PEP07 as a monotherapy.
to know the PK profile
Time frame: 6 months
To assess preliminary evidence of anti-tumor activity of PEP07 by progression free survival (PFS).
to know the efficacy
Time frame: after first dosing to disease progression
To assess preliminary evidence of anti-tumor activity of PEP07 by progression free survival (PFS).
to know the efficacy
Time frame: after first dosing to disease progress
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