Actively Recruiting
A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer
Led by PharmaEngine · Updated on 2025-07-31
32
Participants Needed
5
Research Sites
180 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years of age or older.
- Must have relapsed or refractory Acute Myeloid Leukemia (AML) or Mantle Cell Lymphoma (MCL).
- For MCL, must have received at least two prior treatments including chemoimmunotherapy and BTKi and have at least one measurable disease site.
- Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
- Adequate kidney function with creatinine clearance of 50 mL/min or higher.
- Adequate liver function with AST and ALT no more than 2.5 times the upper limit of normal, and bilirubin no more than 1.5 times the upper limit of normal unless due to leukemic organ involvement.
- Left ventricular ejection fraction (LVEF) of 50% or higher.
- Previous adverse events have improved to baseline or Grade 1 or lower.
- Negative pregnancy test for females with reproductive potential within 7 days before treatment.
- Negative COVID-19 test by PCR or rapid antigen test on Day -7 or Day 1.
- Signed and dated informed consent form.
You will not qualify if you...
- Pregnant or breastfeeding females.
- Females of childbearing potential and males with partners of childbearing potential not agreeing to two forms of highly effective contraception during treatment and for 120 days after last dose.
- Received anti-cancer therapy within 14 days or 5 half-lives prior to first dose, except hydroxyurea or dexamethasone.
- Allogeneic hematopoietic stem cell transplant within 60 days before treatment.
- Use of strong or moderate CYP3A4 inhibitors or inducers within 5 half-lives or 7 days prior to treatment.
- Viral infection with HIV or hepatitis B or C requiring antiviral therapy or with positive serology and viral load above specified thresholds.
- Uncontrolled systemic infection or requiring isolation.
- History of other cancers within last 5 years except certain treated skin or cervical cancers or myelodysplastic syndromes.
- Ongoing Grade 2 or higher toxicity related to prior treatment (except alopecia and hot flashes).
- Baseline QTc interval greater than 450 msec.
- Significant heart disease including NYHA Class III or higher, low LVEF under 45%, recent cardiac ischemia or arrhythmia.
- Major surgery within 3 weeks before first dose.
- Active central nervous system or leptomeningeal involvement.
- Major cardiovascular events within 6 months before treatment.
- History of allergic reactions to PEP07 components.
- Other medical or psychiatric conditions that may interfere with participation.
- Any other condition deemed ineligible by the principal investigator or designee.
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
2
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
3
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
4
Chang Gung Memorial Hospital- Linkou
Taipei, Taiwan
Actively Recruiting
5
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
B
Brian Shen
CONTACT
J
John Lin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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