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

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.

NCT Number	NCT06973863
Lead Sponsor	PharmaEngine
Conditions	Advanced Solid Tumor, Solid Tumors, MTAP-deleted Solid Tumors, MTAP Deletion
Enrollment	40 participants
Start Date	2025-08-26
Primary Completion	2027-12 (estimated)
Study Completion	2028-03 (estimated)
Updated on ClinicalTrials.gov	2026-02-13