Advanced Solid TumorPhase 1NCT06973863
A Study of PEP08 in Patients With MTAP-Del Advanced or Metastatic Solid Tumors
A Phase 1 study testing PEP08 in people with Advanced Solid Tumor and Solid Tumors, run by PharmaEngine at 4 sites in 2 countries.
Trial summary
This is a first-in-human clinical study of PEP08, a novel cancer therapy being evaluated both as monotherapy and in combination with other treatments in patients with advanced or metastatic solid tumors harboring MTAP deletion. The study will be conducted in three parts, with Part 1 currently open for enrollment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Solid Tumors, MTAP-deleted Solid Tumors
- What is being tested?
- PEP08
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 26 Aug 2025to Mar 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be adults (≥18 years) and sign informed consent before undergoing any study-related procedures.
- Eligible participants must have advanced or metastatic solid tumors that are not treatable with surgery or radiation, and show evidence of MTAP gene homozygous deletion or MTAP protein loss based on tumor tissue analysis.
- Participants must have previously received standard treatment for their cancer type, and either experienced disease progression, be refractory, or be intolerant to such therapies.
- At least one measurable lesion is required, evaluated by standard imaging criteria (RECIST v1.1).
- Good general physical condition (ECOG performance status 0-1 for dose escalation; broader range allowed for other parts).
- Adequate function in key organs.
- Able to swallow oral medication and comply with study requirements.
- Women of childbearing potential and men with reproductive potential must use effective contraception during and after the study.
Who cannot join
- Recent cancer treatment, immunotherapy, or investigational drugs are not allowed before starting the study.
- Live vaccines received shortly before treatment are not allowed.
- Previous use of drugs with similar mechanisms to the study treatment is not allowed.
- Active or unstable brain or meningeal metastases, unless previously treated and stable without needing local treatment or high-dose steroids.
- History of other cancers within the last 2 years, unless low-risk and treated (e.g., in situ or certain skin cancers).
- Uncontrolled disease-related complications (e.g., abnormal calcium levels, fluid buildup around organs).
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- Active HIV, hepatitis B or C infections that are not well-controlled.
- Ongoing serious infections or systemic conditions requiring isolation.
- Significant heart disease, such as recent heart failure, ischemia, or arrhythmias.
- History of severe digestive conditions or surgeries affecting drug absorption.
- Recent major surgery.
- Unresolved serious side effects from prior cancer treatment.
- Currently pregnant or breastfeeding.
- Poorly controlled blood pressure or lung conditions.
- Other serious illnesses (e.g., severe anemia, psychiatric or social issues affecting study compliance).
- Any condition that may pose a safety risk or interfere with the study, as judged by the investigator.
- Known drug or substance abuse that may affect study participation.
- Allergy to the study drug or any of its components.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Taiwan3 sites, 3 recruiting
- Recruiting
China Medical University Hospital
Taichung
- Recruiting
National Taiwan University Hospital
Taipei
- Recruiting
Taipei Veterans General Hospital
Taipei
Australia1 site, 1 recruiting
- Recruiting
Westmead Hospital
Wentworthville, New South Wales, 2145
About this study
Official title: A Phase 1a/1b Study Evaluating the Clinical Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Efficacy of PEP08 as Monotherapy and Combination Therapy in MTAP-Del Advanced or Metastatic Solid Tumors
This is a first-in-human clinical study of PEP08, a novel cancer therapy being evaluated both as monotherapy and in combination with other treatments in patients with advanced or metastatic solid tumors harboring MTAP deletion.
The study will be conducted in three parts, with Part 1 currently open for enrollment.
Read more
The primary objectives of the study are to:
- Evaluate the safety and tolerability of PEP08, PK and PD
- Determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
- Assess preliminary signs of anti-tumor activity of PEP08
Key study questions include:
- What is the recommended dose of PEP08 for further development?
- Wht is the tolerable dose of PEP08 when administered alone or in combination?
- Does PEP08 show early evidence of clinical activity in patients with MTAP-deleted tumors?
Participants in the study will:
- Receive PEP08 alone or in combination with another anti-cancer agent, depending on the study part
- Attend regular clinic visits for treatment administration, laboratory assessments, and tumor evaluations
- Be enrolled in one of the following study phases over time:
- - Part 1: Monotherapy dose escalation (currently enrolling).
- - Parts 2 and 3 (monotherapy extension and combination therapy) will be activated in future protocol amendments.
- Being tested
- PEP08
- Keywords
- MTAP-del, PRMT5 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP08Drug
PEP08 is an oral, potent, MTA-cooperative PRMT5 inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| PEP08 monotherapy and expansion in advanced or metastatic solid tumors | Experimental | This arm of the study involves dose escalation to evaluate the tolerability and response of PEP08 monotherapy. Participants in this arm will receive daily dosing and be regularly monitored. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. Receives: Drug: PEP08 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events (AE)
Measured: Up to 2 years
Number of Participants Experiencing Serious Adverse Events (SAE)
Measured: Up to 2 years
Number of Patients who Experience Dose-Limiting Toxicity
Measured: 21 days
Secondary outcomes (6)
Area under the plasma concentration versus time curve (AUC)
Measured: Up to 6 days
Maximum observed plasma concentration (Cmax)
Measured: Up to 6 days
Maximum observed plasma concentration (Cmin)
Measured: Up to 6 days
Time to achieve maximal plasma concentration (Tmax)
Measured: Up to 6 days
Terminal elimination half-life (t1/2)
Measured: Up to 6 days
Objective Response Rate (ORR) per RECIST v1.1
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start26 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PharmaEngine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973863
- Sponsor's protocol ID
- PEP08-101
- Status last verified
- Feb 2026
- First submitted
- 7 May 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Study Evaluating the Clinical Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Efficacy of PEP08 as Monotherapy and Combination Therapy in MTAP-Del Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06973863
- Acronym / sponsor ID
- PEP08-101
- Keywords
- MTAP-del, PRMT5 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- PharmaEngineIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 15 May 2025 (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.
This is a first-in-human clinical study of PEP08, a novel cancer therapy being evaluated both as monotherapy and in combination with other treatments in patients with advanced or metastatic solid tumors harboring MTAP deletion.
The study will be conducted in three parts, with Part 1 currently open for enrollment.
The primary objectives of the study are to:
- Evaluate the safety and tolerability of PEP08, PK and PD
- Determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
- Assess preliminary signs of anti-tumor activity of PEP08
Key study questions include:
- What is the recommended dose of PEP08 for further development?
- Wht is the tolerable dose of PEP08 when administered alone or in combination?
- Does PEP08 show early evidence of clinical activity in patients with MTAP-deleted tumors?
Participants in the study will:
- Receive PEP08 alone or in combination with another anti-cancer agent, depending on the study part
- Attend regular clinic visits for treatment administration, laboratory assessments, and tumor evaluations
- Be enrolled in one of the following study phases over time:
- - Part 1: Monotherapy dose escalation (currently enrolling).
- - Parts 2 and 3 (monotherapy extension and combination therapy) will be activated in future protocol amendments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEP08 monotherapy and expansion in advanced or metastatic solid tumors | Experimental | Drug: PEP08This arm of the study involves dose escalation to evaluate the tolerability and response of PEP08 monotherapy. Participants in this arm will receive daily dosing and be regularly monitored. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must be adults (≥18 years) and sign informed consent before undergoing any study-related procedures.
- Eligible participants must have advanced or metastatic solid tumors that are not treatable with surgery or radiation, and show evidence of MTAP gene homozygous deletion or MTAP protein loss based on tumor tissue analysis.
- Participants must have previously received standard treatment for their cancer type, and either experienced disease progression, be refractory, or be intolerant to such therapies.
- At least one measurable lesion is required, evaluated by standard imaging criteria (RECIST v1.1).
- Good general physical condition (ECOG performance status 0-1 for dose escalation; broader range allowed for other parts).
Key exclusion criteria (18 listed)
- Recent cancer treatment, immunotherapy, or investigational drugs are not allowed before starting the study.
- Live vaccines received shortly before treatment are not allowed.
- Previous use of drugs with similar mechanisms to the study treatment is not allowed.
- Active or unstable brain or meningeal metastases, unless previously treated and stable without needing local treatment or high-dose steroids.
- History of other cancers within the last 2 years, unless low-risk and treated (e.g., in situ or certain skin cancers).
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 |
|---|---|---|
| PEP08PEP08 is an oral, potent, MTA-cooperative PRMT5 inhibitor. | Drug | PEP08 monotherapy and expansion in advanced or metastatic solid tumors |
Primary outcome
Number of Participants Experiencing Adverse Events (AE)
Time frame: Up to 2 years
Number of Participants Experiencing Serious Adverse Events (SAE)
Time frame: Up to 2 years
Number of Patients who Experience Dose-Limiting Toxicity
Time frame: 21 days
6 secondary outcomes
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 6 days
Maximum observed plasma concentration (Cmax)
Time frame: Up to 6 days
Maximum observed plasma concentration (Cmin)
Time frame: Up to 6 days
Time to achieve maximal plasma concentration (Tmax)
Time frame: Up to 6 days
Terminal elimination half-life (t1/2)
Time frame: Up to 6 days
Objective Response Rate (ORR) per RECIST v1.1
Time frame: Up to 2 years
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 13 Feb 2026.
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEP08 in people with Advanced Solid Tumor and Solid Tumors, run by PharmaEngine at 4 sites in 2 countries.
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 8 inclusion and 18 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 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan, Australia. 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 Project Manager (+886 2 2515 8228 ext. ext 205, hannie.yu@pharmaengine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Adverse Events (AE) (time frame: Up to 2 years). The study lists 3 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 13 Feb 2026.