Health Trials

First-in-human Trial of PhOx430, a First-in-class Acetylglucosaminyltransferase V Inhibitor, in Advanced Solid Tumours

ConditionsMalignant TumorAdvanced Solid TumorGlioblastoma MultiformeMetastatic Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPhost'In Therapeutics

About this trial

The PhAST Trial is an adaptive first-in-human clinical trial of the acetylglucosaminyltransferase V inhibitor PhOx430 in patients with advanced solid tumours conceived and designed with the contribution of the Gianni Bonadonna Foundation, a non-profit academic research institution aimed at promoting therapeutic innovation in oncology.. The trial includes two parts, a dose escalation phase which will enroll patients with non-selected tumour types, followed by a cohort expansion phase in selected tumour types.

Eligibility criteria

Qualifiers

Histologically or cytologically confirmed diagnosis of cancer.

Dose escalation phase: patients with any solid tumour type or histology.

Expansion cohort 1: Patients affected by GBM.

Expansion cohort 2: Patients with triple-negative breast cancer (TNBC), defined as estrogen receptor (ER) negative (< 1% of nuclei reacting for ER in IHC), progesterone receptor (PgR) negative (< 1% of nuclei reacting for PgR in IHC), HER2 negative (IHC score = 0 or 1 or ICH score = 2 with FISH negative for HER2 overexpression. If only FISH was performed, negative result for HER2 overexpression).

Disqualifiers

Major surgery, chemotherapy, radical radiotherapy, investigational agents, or other anticancer therapy in the last 4 weeks before treatment start.

For all patients with the exception of GBM patients: active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (subjects with a history of CNS metastases or cord compression are allowable if they have been definitively treated and have been clinically stable for at least 3 months, and off steroids or anticonvulsants, before day 1 treatment).

For GBM patients: disease progression within three months following last prior radiation therapy.

Inability or unwillingness to swallow.

Trial design

Treatments tested in this trial

  • PhOx430
  • PhOx430

Treatment groups

149 Participants
are divided into 1 treatment group

Sponsors and collaborators

Phost'In Therapeutics

Lead sponsor

Source ClinicalTrials.gov