PEP08 for adults with advanced MTAP‑deleted solid tumors
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
Run by PharmaEngine · NCT06973863 · Data updated 2026-11-12
This trial will test whether PEP08, given alone or with another cancer drug, is safe and shows signs of benefit in adults with advanced or metastatic solid tumors that have MTAP deletion.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | PharmaEngine Industry-sponsored |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 4 sites (Wentworthville, New South Wales and 3 other locations) |
| Status | Recruiting |
| Started | August 26, 2025 |
| Main results expected | December 2027 |
| Study ends | March 2028 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT06973863 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with advanced or metastatic solid tumors that are not amenable to curative treatment and have confirmed MTAP homozygous deletion or protein loss, measurable disease, prior standard therapy, good organ function, and the required performance status are ideal candidates.
✕Probably not a fit
Patients whose tumors do not have MTAP deletion, who are eligible for effective standard curative treatments, or who are medically unfit due to poor organ function or performance status are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a first‑in‑human, Phase 1 dose‑finding study of PEP08 in patients with advanced or metastatic solid tumors harboring MTAP deletion. The trial includes multiple parts with dose escalation to determine the maximum tolerated dose and recommended Phase 2 dose, with some parts testing PEP08 in combination with another anti‑cancer agent. Key endpoints include safety, pharmacokinetics/pharmacodynamics, and preliminary anti‑tumor activity measured by standard imaging criteria. Eligible patients must have confirmed MTAP homozygous deletion or protein loss and measurable disease and will attend regular clinic visits for dosing and monitoring.
Why it matters
Potential benefit: If successful, PEP08 could become a new targeted treatment option for patients with MTAP‑deleted advanced solid tumors who have exhausted standard therapies.
How similar studies have gone: Related approaches targeting PRMT5 or exploiting MTAP deletion have shown encouraging signals in preclinical work and early‑phase trials, but the strategy remains experimental and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Westmead Hospital
Wentworthville, New South Wales, Australia Recruiting -
China Medical University Hospital
Taichung, Taiwan Recruiting -
National Taiwan University Hospital
Taipei, Taiwan Recruiting -
Taipei Veterans General Hospital
Taipei, Taiwan Recruiting
Study contacts
- Study coordinator: Project Manager
- Email: hannie.yu@pharmaengine.com
- Phone: +886 2 2515 8228
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
BG-C0902 alone and with other therapies for people with advanced solid tumors
This study will test whether BG-C0902, given alone or with other cancer drugs, is safe and can shrink tumors in people with advanced solid tumors.
-
BA1203 in advanced solid tumors: safety and early signs of activity
This early-phase trial tests BA1203 in adults with advanced solid tumors to see if it is safe, tolerable, how the drug behaves in the body, and whether it shows any early signs of effectiveness.
-
BL-M08D treatment in melanoma and other solid tumors
A phase Ib/II study tests BL-M08D1 injections in adults with locally advanced or metastatic melanoma and other solid tumors to see if it is safe and helpful.
-
REC-7735 for PIK3CA-H1047R-mutant solid tumors
This study tests REC-7735 in people with unresectable, locally advanced, or metastatic solid tumors that carry the PIK3CA-H1047R mutation.
-
Preferences of physicians and patients for cell therapies in advanced solid tumors
This study tests how doctors and patients weigh the benefits, risks, and burdens of CAR-T, TIL, TCR-T, and NK cell therapies in advanced solid cancers.
-
SGT003 in people with advanced solid tumors
This early-phase study tests SGT003 in adults with advanced solid tumors to see if it is safe and tolerable and to get a first look at how it behaves in the body and any early signs of benefit.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.