NCT05495295 First-in-human Trial of PhOx430, a First-in-class Acetylglucosaminyltransferase V Inhibitor, in Advanced Solid Tumours

Trial Parameters

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Brief Summary

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

Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of cancer. 1. Dose escalation phase: patients with any solid tumour type or histology. 2. Expansion cohort 1: Patients affected by GBM. 3. 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). 4. Expansion cohort 3: Patients affected by solid tumour types selected by the PSC, on the basis of preclinical pharmacological data and of the antitumour activity observed during the dose escalation phase if any. 2. Radiologically documented progressive disease after at least one prior treatment for metastatic/advanced disease. 3. Lack of standard effective treatment options. 4. F

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