A Study of PEP08 in Patients With MTAP-Del Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPharmaEngine
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
PEP08
DrugPEP08 is an oral, potent, MTA-cooperative PRMT5 inhibitor.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: PEP08 monotherapy and expansion in advanced or metastatic solid tumorsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants Experiencing Adverse Events (AE)
Time frame
Up to 2 years2
Number of Participants Experiencing Serious Adverse Events (SAE)
Time frame
Up to 2 years3
Number of Patients who Experience Dose-Limiting Toxicity
Time frame
21 daysSecondary outcomes
1
Area under the plasma concentration versus time curve (AUC)
Time frame
Up to 6 days2
Maximum observed plasma concentration (Cmax)
Time frame
Up to 6 days3
Maximum observed plasma concentration (Cmin)
Time frame
Up to 6 days4
Time to achieve maximal plasma concentration (Tmax)
Time frame
Up to 6 daysSponsors and contacts
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Source ClinicalTrials.gov