A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPharmaEngine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be ≥ 18 years of age.
Relapsed or refractory AML (by the 5th edition of World Health Organization [WHO] classification of Hematolymphoid tumors)
OR Relapsed or refractory MCL and have received at least two prior lines of treatment, including chemoimmunotherapy and BTKi and at least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma.
Must have Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
Disqualifiers
Pregnant or breastfeeding females
Females of childbearing potential and males whose partners are of childbearing potential who do not agree to the use of 2 forms of highly effective contraception during the treatment period and for 120 days after the last dose of PEP07.
Patients who have received anti-cancer therapy including chemotherapy, radiotherapy, hormonal, or any investigational therapy within 14 days or 5 half-lives (whichever is shorter), or immunotherapy within 30 days prior to the first dose of PEP07. Patients who have received hydroxyurea or dexamethasone at any time prior to the start of study treatment is an exception to this criterion.
Patients who have undergone allogeneic hematopoietic stem cell transplant (HSCT) within 60 days of PEP07 treatment.
Trial design
Design model
Single group
Treatments tested in this trial
PEP07
DrugPEP07 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.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: PEP07 Monotherapy (Arm A)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 AML and MCL.
to find out the DLT
Time frame
4 weeks after first dosing2
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 dosingSecondary outcomes
1
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 months2
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 months3
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 months4
To assess the Maximum observed concentration (Cmax) of single and multiple oral PEP07 as a monotherapy.
to know the PK profile
Time frame
6 monthsOther outcomes
1
To assess Chk1 level in patients with AML and MCL.
to find out the the changes in biomarkers
Time frame
6 months2
To assess γH2AX level in patients with AML and MCL.
to find out the the changes in biomarkers
Time frame
6 months3
To assess pCHK1 level in patients with AML and MCL.
to find out the the changes in biomarkers
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov