A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients with Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20+
SponsorPharmaEngine
About this trial
The goal of this clinical trial is To establish the safety profile and determine the dose-limited toxicity (DLT) of PEP07 monotherapy in patients with advanced or metastatic solid tumors. 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, 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
Aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN, if attributable to liver metastases)
Alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN, if attributable to liver metastases)
Bilirubin ≤ 1.5 × ULN
Absolute neutrophil count (ANC) ≥ 1500/mm3
Disqualifiers
Pregnant or breastfeeding females.
Subjects 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 study treatment.
Subjects have received strong or moderated cytochrome P450 3A4 (CYP3A4) inhibitors or CYP inducers such as ketoconazole, erythromycin, netupitant, isavuconazole etc. within 5 half-lives or 7 days (whichever is the shortest) prior to the first dose of study treatment.
Known history of or positive screening result for human immunodeficiency virus (HIV) antibody.
Trial design
Design model
Single group
Treatments tested in this trial
PEP07
DrugPEP07 is a potent, highly selective, orally bioavailable small molecule inhibitor of Chk1. 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
54 Participants
are divided into 1 treatment groupGroup A: PEP07 MonotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
to find out the DLT
To establish the safety profile and determinate the dose-limited toxicity (DLT) of PEP07 monotherapy
Time frame
4 weeks after first dosing2
to find out the MTD and RP2D
To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of PEP07 monotherapy
Time frame
4 weeks after first dosingSecondary outcomes
1
to know the PK profile
To assess the area under the plasma concentration versus time curve (AUC) of PEP07 as a monotherapy
Time frame
6 months2
to know the PK profile
To assess the time to maximun (peak) plasma concentration (Tmax) of PEP07 as a monotherapy
Time frame
6 months3
to know the PK profile
To assess the apparent half-life (t 1/2) of PEP07 as a monotherapy
Time frame
6 months4
to know the PK profile
To assess the peak plasma concentration (Cmax) of PEP07 as a monotherapy
Time frame
6 monthsOther outcomes
1
to find out the change in biomarkers
To assess Chk1 level in subjects with advanced or metastatic solid tumors
Time frame
6 months2
to find out the change in biomarkers
To assess γH2AX level in subjects with advanced or metastatic solid tumors
Time frame
6 months3
to find out the change in biomarkers
To assess pCHK1 level in subjects with advanced or metastatic solid tumors
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov