Actively Recruiting
A Study of PEP08 in Patients With MTAP-Del Advanced or Metastatic Solid Tumors
Led by PharmaEngine · Updated on 2026-02-13
40
Participants Needed
4
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of PEP08 in Patients With MTAP-Del Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older who provide informed consent
- Diagnosed with advanced or metastatic solid tumors not treatable with surgery or radiation
- Tumors must have confirmed MTAP gene homozygous deletion or MTAP protein loss based on tissue analysis
- Previously treated with standard therapies and experienced progression, resistance, or intolerance
- At least one measurable tumor lesion per RECIST v1.1 criteria
- Good general health with ECOG performance status 0-1 in dose escalation phase
- Adequate function of key organs
- Able to swallow oral medication and follow study procedures
- Women of childbearing potential and men with reproductive potential must agree to use effective contraception during and after the study
You will not qualify if you...
- Recent cancer treatments, immunotherapy, or investigational drugs before study start
- Receipt of live vaccines shortly before treatment
- Previous use of drugs with mechanisms similar to PEP08
- Active or unstable brain or meningeal metastases unless stable and treated without high-dose steroids
- History of other cancers within 2 years unless low-risk and treated (e.g., certain skin cancers)
- Uncontrolled disease complications such as abnormal calcium or fluid buildup
- Active HIV, hepatitis B or C infections that are not well controlled
- Serious infections or systemic conditions requiring isolation
- Significant heart disease like recent heart failure or arrhythmias
- Severe digestive disorders or surgeries affecting drug absorption
- Recent major surgery
- Unresolved severe side effects from prior cancer therapy
- Currently pregnant or breastfeeding
- Poorly controlled blood pressure or lung disease
- Serious illnesses or psychiatric/social issues that interfere with study compliance
- Any condition posing safety risks or interfering with the study as judged by the investigator
- Known drug or substance abuse affecting participation
- Allergy to PEP08 or its components
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Westmead Hospital
Wentworthville, New South Wales, Australia, 2145
Actively Recruiting
2
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
3
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
4
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
P
Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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