Actively Recruiting
A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients with Advanced or Metastatic Solid Tumors
Led by PharmaEngine · Updated on 2024-11-07
54
Participants Needed
3
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients with Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older
- For dose escalation: advanced or metastatic solid tumors with failure or intolerance to standard treatments or no access to them
- For dose expansion: confirmed malignant advanced or metastatic solid tumors with failure or intolerance to standard treatments or no access to them
- At least one measurable tumor lesion per RECIST 1.1
- ECOG performance status of 0 or 1
- Adequate kidney function with creatinine clearance 8 mL/min
- Adequate liver function with AST �b4 2.5 times upper limit of normal (ULN) or 5 times ULN if due to liver metastases, ALT �b4 2.5 times ULN or 5 times ULN if due to liver metastases, and bilirubin �b4 1.5 times ULN
- Adequate bone marrow function with ANC �b500/mm3, platelets �b100,000/mm3, and hemoglobin �b9 g/dL
- Negative pregnancy test within 7 days before first dose for women with reproductive potential
- Agreement to use effective contraception during study and for 6 months after last dose
- Signed informed consent form
You will not qualify if you...
- Pregnant or breastfeeding women
- Anti-cancer therapy including chemotherapy, radiotherapy, hormonal or investigational therapy within 14 days or immunotherapy within 30 days before first dose
- Use of strong or moderate CYP3A4 inhibitors or inducers within 5 half-lives or 7 days before first dose
- Known HIV infection
- Active viral hepatitis B or C requiring antiviral therapy or with high viral load
- Uncontrolled systemic infections or requiring isolation
- Other cancers in the past 5 years except certain treated skin cancers, cervical carcinoma in situ, or myelodysplastic syndromes
- Ongoing grade 2 or higher toxicity from previous treatment except hair loss or hot flashes
- QTcF interval over 450 msec at screening
- Severe cardiovascular conditions including NYHA class III or higher, low heart function, recent cardiac ischemia, or arrhythmia
- Major surgery within 3 weeks before first dose
- Active central nervous system or leptomeningeal metastases unless stable and asymptomatic
- Recent serious heart or neurological events within 6 months
- Other medical or psychiatric conditions interfering with participation or study results
AI-Screening
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Trial Site Locations
Total: 3 locations
1
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
2
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
3
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
Z
Zoe Wu
CONTACT
W
Wei Che Yu
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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