Recruiting

PEP08 for MTAP-Deleted Advanced Solid Tumors

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What is being tested

PEP08

Drug
Who is being recruted

Over 18 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorPharmaEngine
Study ContactProject Manager
Last updated: February 14, 2026
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Study start date: August 26, 2025

Actual date on which the first participant was enrolled.

This clinical trial aims to explore a new cancer treatment called PEP08 for patients with advanced or metastatic solid tumors that have a specific genetic feature known as MTAP deletion. The study is important because it could lead to new treatment options for people with these types of tumors, who may have limited choices available. The main goals are to determine if PEP08 is safe and to find out the right dose to use in future studies. Additionally, researchers are looking to see if PEP08 can help reduce tumor size in these patients. Participants in the study will receive PEP08 either by itself or combined with another cancer drug, depending on the part of the study they join. The study is conducted in phases, starting with a focus on PEP08 alone, with later phases planned to explore combination treatments. Participants will visit the clinic regularly for treatments, lab tests, and to check tumor progress. The study seeks to establish the safest and most effective dose while monitoring any potential side effects or early signs of the treatment's effectiveness.

Official TitleA 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
NCT06973863
Principal SponsorPharmaEngine
Study ContactProject Manager
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

8 inclusion criteria required to participate
Adequate function in key organs.
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.
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18 exclusion criteria prevent from participating
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.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
This arm of the study involves dose escalation to evaluate the tolerability and response of PEP08 monotherapy. Participants in this arm will receive daily dosing and be regularly monitored. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Recruiting

Westmead Hospital

Wentworthville, AustraliaOpen Westmead Hospital in Google Maps
Recruiting

China Medical University Hospital

Taichung, Taiwan
Recruiting

National Taiwan University Hospital

Taipei, Taiwan
Recruiting

Taipei Veterans General Hospital

Taipei, Taiwan
Recruiting
4 Study Centers