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

NCT06973863 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-13

No results posted yet for this study

Summary

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

  • Advanced Solid Tumor
  • Solid Tumors
  • MTAP-deleted Solid Tumors
  • MTAP Deletion

Interventions

DRUG

PEP08

PEP08 is an oral, potent, MTA-cooperative PRMT5 inhibitor.

Sponsors & Collaborators

  • PharmaEngine

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-26
Primary Completion
2027-12-31
Completion
2028-03-31

Countries

  • Australia
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06973863 on ClinicalTrials.gov