New pill targets Hard-to-Treat cancers in early human trial
NCT ID NCT06973863
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study is testing a new oral drug called PEP08 in up to 40 adults with advanced or metastatic solid tumors that have lost a gene called MTAP. The drug works by blocking a protein that cancer cells need to grow. The main goals are to check safety, find the right dose, and see if the drug shows any signs of shrinking tumors. The trial is currently recruiting for the first part, which tests PEP08 alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PEP08 (an oral drug that targets a protein called PRMT5, which helps cancer cells grow)
- What this could lead to
- If this early trial shows PEP08 is safe and shrinks tumors, it could point toward a new treatment option for people with certain hard-to-treat cancers that have an MTAP gene deletion.
- What could go wrong
- This is a very early Phase 1 trial with only 40 participants, so it is too soon to know if PEP08 will work or be safe. Many promising cancer drugs fail in early testing, and side effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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). * 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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China Medical University Hospital
RECRUITINGTaichung, Taiwan
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National Taiwan University Hospital
RECRUITINGTaipei, Taiwan
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Taipei Veterans General Hospital
RECRUITINGTaipei, Taiwan
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Westmead Hospital
RECRUITINGWentworthville, New South Wales, 2145, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors