Advanced Solid TumorPhase 1NCT05983523
A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients with Advanced or Metastatic Solid Tumors
A Phase 1 study testing PEP07 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by PharmaEngine at 3 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Tumor, Metastatic Solid Tumor
- What is being tested?
- PEP07
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesTaiwan
- Study dates
- 27 Mar 2024to 31 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subjects must be ≥ 20 years of age
- 2a. For subject in the dose escalation stage: Subjects with advanced or metastatic solid tumors who have failed on or are intolerant to standard treatment or have no access to standard treatment.
- 2b. For subject in the dose expansion stage: Subjects with histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, who have failed on or are intolerant to standard treatment or have no access to standard treatment.
- 3. At least one measurable lesion according to the RECIST version 1.1.
- 4. Subjects must have ECOG Performance score of 0-1.
- 5. Subject 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.
Show all 16Show fewer
- 6. Subject must have adequate liver function as demonstrated by:
- 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
- 7. Subject must have adequate bone marrow function as demonstrated by:
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelet counts ≥ 100,000/mm3
- Hemoglobin ≥ 9 g/dL
- 8. Female subjects with reproductive potential must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment. Women of childbearing potential as well as males of reproductive potential must agree to refrain from unprotected sex and ensure highly effective contraception with partner during study period and until 6 months after the last dose of study drug.
- 9. Provision of signed and dated informed consent form.
Who cannot join
- 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.
- Viral hepatitis type B or C which require antiviral therapy, and/or have HBsAg (+) with HBV DNA ≥ 1000 IU/mL, or anti-HCV Ab (+) with HCV RNA (+). If a patient with HBsAg (+) then HBV DNA needs to be tested. If a patient with anti-HCV Ab (+) then the patient needs to be followed for HCV RNA (-) to be enrolled.
- Uncontrolled systemic infection /or requiring isolation.
Show all 14Show fewer
- 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).
- Subjects with ongoing ≥ Grade 2 (CTCAE v5.0) toxicity (except alopecia and hot flashes) related to previous treatment.
- Subjects have baseline QTcF interval > 450 msec at screening (within 28 days prior to the first dose of study treatment, mean of triplicate readings within approximately 5 minutes).
- Subjects have 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 history of cardiac arrhythmia requiring treatment.
- Subjects have undergone any major surgery within 3 weeks prior to the first dose of study treatment.
- Subjects with known active central nervous system (CNS) or leptomeningeal metastases. Subjects with previously-treated brain or meningeal metastases may participate and be eligible for treatment provided they are stable and asymptomatic (without evidence of progression by imaging of the brain at least 4 weeks prior to the first dose of study treatment), and are not using excessive steroids (defined as a prednisolone dose ≤ 10 mg daily or equivalent) for at least 2 weeks prior to the first dose of study treatment.
- Subjects have had any of the following within 6 months prior to the first dose of study treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or seizure disorder.
- Subjects have any other medical or psychiatric condition that, in the opinion of the investigator, might interfere with the subject's participation in the trial or interfere with the interpretation of trial results.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan3 sites, 3 recruiting
- Recruiting
China Medical University Hospital
Taichung
Li Yuan Bai, MD, +886 4 2205-2121, lybai6@gmail.com
- Recruiting
National Taiwan University Hospital
Taipei
Chia Chi Lin, MD, +886 2 2312-3456, cclin1@ntu.edu.tw
- Recruiting
Taipei Veterans General Hospital
Taipei
Nai Jung Chiang, MD, +886 2 2871-2121, njchiang@vghtpe.gov.tw
About this study
Official title: A Phase I Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients with Advanced or Metastatic Solid Tumors
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.
Read the detailed description
This is a Phase 1, open-label, multi-center study recruiting patients with advanced or metastatic solid tumors.
The study will utilize an Accelerated Titration Design in the lower dose levels followed by a traditional 3+3 dose escalation design at higher dose levels until RP2D is determined. The starting dose will be 40 mg.
All potential study candidates will provide informed consent and will undergo screening procedures before participating in the study. After a screening period of up to 28 days, qualified patients will be enrolled to receive their assigned dose regimen of PEP07 monotherapy.
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor
- Being tested
- PEP07
- Keywords
- Checkpoint Kinase 1 Inhibitor
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP07Drug
PEP07 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.
| Study group | Role | What they receive |
|---|---|---|
| PEP07 Monotherapy | Experimental | The dose escalation stage of PEP07 monotherapy consists of an accelerated dose escalation followed by a standard "3+3" dose escalation. The accelerated titration will enroll 1 patient in each dose cohort until 1 patient experiences a DLT or a total of 2 patients experience any ≥ grade 2 PEP07-related AE during Cycle 1, and then the dose escalation will be switched to the 3+3 scheme to enroll 3 to 6 patients at the dose cohort where the DLT or the second ≥ grade 2 PEP07-related AE is observed.
To confirm the safety and evaluate the preliminary efficacy of PEP07, expansion cohorts with 12 patients will be opened for PEP07 monotherapy at RP2D once efficacy signal is observed in the dose escalation. Receives: Drug: PEP07 |
What is being measured
The primary outcome is the main question the study is designed to answer.
to find out the DLT
To establish the safety profile and determinate the dose-limited toxicity (DLT) of PEP07 monotherapy
Measured: 4 weeks after first dosing
to find out the MTD and RP2D
To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of PEP07 monotherapy
Measured: 4 weeks after first dosing
Secondary outcomes (7)
to know the PK profile
To assess the area under the plasma concentration versus time curve (AUC) of PEP07 as a monotherapy
Measured: 6 months
to know the PK profile
To assess the time to maximun (peak) plasma concentration (Tmax) of PEP07 as a monotherapy
Measured: 6 months
to know the PK profile
To assess the apparent half-life (t 1/2) of PEP07 as a monotherapy
Measured: 6 months
to know the PK profile
To assess the peak plasma concentration (Cmax) of PEP07 as a monotherapy
Measured: 6 months
to know the efficacy
To assess the preliminary evidence of anti-tumor activities of PEP07 by objective response rate (ORR)
Measured: from date of first dosing until the date of disease progressionfrom date of first dosing until the date of disease progression, assessed up to 12 months
to know the efficacy
To assess the preliminary evidence of anti-tumor activities of PEP07 by objective To assess the preliminary evidence of anti-tumor activities of PEP07 by progression free survival (PFS)
Measured: from date of first dosing until the date of disease progressionfrom date of first dosing until the date of disease progression, assessed up to 12 months
to know the efficacy
To assess the preliminary evidence of anti-tumor activities of PEP07 by overall survival (OS)
Measured: from date of first dosing until the date of disease progressionfrom date of first dosing until the date of disease progression, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start27 Mar 2024
- Primary completion25 Feb 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PharmaEngine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983523
- Sponsor's protocol ID
- PEP07-102
- Status last verified
- Nov 2024
- First submitted
- 24 Jul 2023
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients with Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05983523
- Acronym / sponsor ID
- PEP07-102
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor
- Keywords
- Checkpoint Kinase 1 Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- PharmaEngineIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1, open-label, multi-center study recruiting patients with advanced or metastatic solid tumors.
The study will utilize an Accelerated Titration Design in the lower dose levels followed by a traditional 3+3 dose escalation design at higher dose levels until RP2D is determined. The starting dose will be 40 mg.
All potential study candidates will provide informed consent and will undergo screening procedures before participating in the study. After a screening period of up to 28 days, qualified patients will be enrolled to receive their assigned dose regimen of PEP07 monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEP07 Monotherapy | Experimental | Drug: PEP07The dose escalation stage of PEP07 monotherapy consists of an accelerated dose escalation followed by a standard "3+3" dose escalation. The accelerated titration will enroll 1 patient in each dose cohort until 1 patient experiences a DLT or a total of 2 patients experience any ≥ grade 2 PEP07-related AE during Cycle 1, and then the dose escalation will be switched to the 3+3 scheme to enroll 3 to 6 patients at the dose cohort where the DLT or the second ≥ grade 2 PEP07-related AE is observed. To confirm the safety and evaluate the preliminary efficacy of PEP07, expansion cohorts with 12 patients will be opened for PEP07 monotherapy at RP2D once efficacy signal is observed in the dose escalation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1. Subjects must be ≥ 20 years of age
- 2a. For subject in the dose escalation stage: Subjects with advanced or metastatic solid tumors who have failed on or are intolerant to standard treatment or have no access to standard treatment.
- 2b. For subject in the dose expansion stage: Subjects with histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, who have failed on or are intolerant to standard treatment or have no access to standard treatment.
- 3. At least one measurable lesion according to the RECIST version 1.1.
- 4. Subjects must have ECOG Performance score of 0-1.
Key exclusion criteria (14 listed)
- 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.
- Viral hepatitis type B or C which require antiviral therapy, and/or have HBsAg (+) with HBV DNA ≥ 1000 IU/mL, or anti-HCV Ab (+) with HCV RNA (+). If a patient with HBsAg (+) then HBV DNA needs to be tested. If a patient with anti-HCV Ab (+) then the patient needs to be followed for HCV RNA (-) to be enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEP07PEP07 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. | Drug | PEP07 Monotherapy |
Primary outcome
to find out the DLT
Time frame: 4 weeks after first dosing
To establish the safety profile and determinate the dose-limited toxicity (DLT) of PEP07 monotherapy
to find out the MTD and RP2D
Time frame: 4 weeks after first dosing
To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of PEP07 monotherapy
7 secondary outcomes
to know the PK profile
Time frame: 6 months
to know the PK profile
Time frame: 6 months
to know the PK profile
Time frame: 6 months
to know the PK profile
Time frame: 6 months
to know the efficacy
Time frame: from date of first dosing until the date of disease progressionfrom date of first dosing until the date of disease progression, assessed up to 12 months
to know the efficacy
Time frame: from date of first dosing until the date of disease progressionfrom date of first dosing until the date of disease progression, assessed up to 12 months
to know the efficacy
Time frame: from date of first dosing until the date of disease progressionfrom date of first dosing until the date of disease progression, assessed up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No. no plan to share IPD
Related trials for Advanced Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEP07 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by PharmaEngine at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoe Wu (+886 2 2515-8228, zoe.wu@pharmaengine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to find out the DLT (time frame: 4 weeks after first dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.