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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Experiencing Adverse Events (AE)
Timeframe: Up to 2 years
2
Number of Participants Experiencing Serious Adverse Events (SAE)
Timeframe: Up to 2 years
3
Number of Patients who Experience Dose-Limiting Toxicity