A Study of PEP08 in Patients With MTAP-Del Advanced or Metastatic Solid Tumors

Launched by PHARMAENGINE · May 7, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new cancer treatment called PEP08 in patients with specific types of advanced solid tumors that have a genetic change known as MTAP deletion. The study aims to find out how safe PEP08 is, what the best dose is, and if it can help shrink tumors. The trial is divided into three parts, and right now, they are enrolling participants for the first part, which focuses on testing PEP08 alone.

To join the study, participants need to be adults aged 18 and older with advanced solid tumors that cannot be treated with surgery or radiation. They should have already tried standard treatments but may not have responded well. Participants will take PEP08 either by itself or along with another cancer treatment, attend regular clinic visits for check-ups and evaluations, and the study will monitor their health throughout. It’s important to note that certain health conditions or recent treatments may prevent someone from participating, so the research team will review each person’s medical history carefully.

Gender

ALL

Eligibility 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.