NCT06973863 A Study of PEP08 in Patients With MTAP-Del Advanced or Metastatic Solid Tumors
| NCT ID | NCT06973863 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | PharmaEngine |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-26 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2025-08-26 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06973863 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06973863 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06973863 currently recruiting?
Yes, NCT06973863 is actively recruiting participants. Contact the research team at hannie.yu@pharmaengine.com for enrollment information.
Where is the NCT06973863 trial being conducted?
This trial is being conducted at Wentworthville, Australia, Taichung, Taiwan, Taipei, Taiwan, Taipei, Taiwan.
Who is sponsoring the NCT06973863 clinical trial?
NCT06973863 is sponsored by PharmaEngine. The trial plans to enroll 40 participants.