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New treatment option for Acute Myeloid Leukemia
Official title A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer
ClinicalTrials.gov ID: NCT05659732
What this study is testing
What is PEP07?
PEP07 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must be ≥ 18 years of age.
- Must have histological or cytological confirmation advanced hematologic malignancy including:
- 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...
- Must have Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
You likely can't join if
- 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...
- Patients who have received anti-cancer therapy including chemotherapy, radiotherapy, hormonal, or any investigational therapy within 14 days or 5...
- Patients who have undergone allogeneic hematopoietic stem cell transplant (HSCT) within 60 days of PEP07 treatment.
- Patients who have received strong or moderate CYP3A4 inhibitors or inducers such as ketoconazole, erythromycin, netupitant, isavuconazole etc. within...
- Viral infection with HIV or viral hepatitis type B or C which require antiviral therapy and/or have positive serology test of hepatitis B surface...
See the full eligibility criteria
Who can join
- Must be ≥ 18 years of age.
- Must have histological or cytological confirmation advanced hematologic malignancy including:
- 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...
- Must have Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
- Must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 50 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.
- Must have adequate liver function as demonstrated by:
- aspartate aminotransferase (AST) ≤ 2.5 × ULN
- alanine aminotransferase (ALT) ≤ 2.5 × ULN
- bilirubin ≤ 1.5 × ULN (unless considered due to leukemic organ involvement. Patients with Gilbert's Syndrome may have had a bilirubin \> 1.5 × ULN per discussion between the PI or designee and sponsor)
- Left ventricular ejection fraction (LVEF) ≥ 50% measured by multiple-gated acquisition (MUGA) or echocardiogram.
- Previous AEs have been improved to baseline or Grade ≤ 1 NCI CTCAE v5.0.
- Female patients with reproductive potential must have a negative serum pregnancy test 7 days prior to the administration of PEP07.
- Patients will be required to have a Covid negative test either via reverse transcriptase polymerase chain reaction (RTPCR) or a rapid antigen test (RAT) test on Day -7/Day 1.
- Provision of signed and dated informed consent form.
What rules you out
- 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...
- 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...
- Patients who have undergone allogeneic hematopoietic stem cell transplant (HSCT) within 60 days of PEP07 treatment.
- Patients who have received strong or moderate CYP3A4 inhibitors or inducers such as ketoconazole, erythromycin, netupitant, isavuconazole etc. within 5 half-lives or 7 days (whichever is the shortest) prior to the...
- Viral infection with HIV or viral hepatitis type B or C which require antiviral therapy and/or have positive serology test of hepatitis B surface antigen [HBsAg (+)] with HBV DNA ≥ 1000 IU/mL, or hepatitis C virus...
- Uncontrolled systemic infection /or requiring isolation.
- Patients with previous history of other malignant diseases within the last 5 years (other than adequately treated non-melanotic skin cancer, in-situ carcinoma of the uterine cervix or myelodysplastic syndromes).
- Patients with ongoing ≥ Grade 2 (CTCAE v5.0) toxicity (except alopecia and hot flashes) related to previous treatment.
- Patients with baseline QTc interval \> 450 msec (i.e., CTCAE Grade ≥ 2) at screening (within 28 days prior to 1st dose of PEP07, mean of triplicate readings within approximately 5 minutes).
- Patients with cardiovascular disability status of New York Heart Association (NYHA) ≥ Class III, left ventricular ejection fraction \< 45 % at baseline, history of cardiac ischemia within the past 6 months, or prior...
- Patients who have undergone any major surgery within 3 weeks prior to first study drug administration after enrollment.
- Patients with known active central nervous system (CNS) or leptomeningeal involvement.
- Patients who have had any of the following within 6 months prior to first administration of PEP07 after enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft...
- Have a history of hypersensitivity reactions or allergic reactions to PEP07 excipients and components.
- Patients with other medical or psychiatric condition that, in the opinion of the investigator, might interfere with the patient's participation in the trial or interfere with the interpretation of trial results.
- Others who are ineligible to participate in this clinical study as determined by the PI or designee.
The study team makes the final eligibility decision.
Where it's taking place
- Clayton, Victoria, Australia
- Kaohsiung City, Taiwan
- Taichung, Taiwan
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clayton, Victoria, Australia; Kaohsiung City, Taiwan; Taichung, Taiwan; Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.