OncoMatch/Clinical Trials/NCT05495295
First-in-human Trial of PhOx430, a First-in-class Acetylglucosaminyltransferase V Inhibitor, in Advanced Solid Tumours
Is NCT05495295 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including PhOx430 and PhOx430 for malignant tumor.
Treatment: PhOx430 · PhOx430 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Glioblastoma
Biomarker criteria
Required: ESR1 negative (< 1% of nuclei reacting for ER in IHC) (< 1% of nuclei reacting for ER in IHC)
estrogen receptor (ER) negative (< 1% of nuclei reacting for ER in IHC)
Required: PR (PGR) negative (< 1% of nuclei reacting for PgR in IHC) (< 1% of nuclei reacting for PgR in IHC)
progesterone receptor (PgR) negative (< 1% of nuclei reacting for PgR in IHC)
Required: HER2 (ERBB2) 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) (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)
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)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: any systemic therapy — metastatic/advanced
Radiologically documented progressive disease after at least one prior treatment for metastatic/advanced disease.
Cannot have received: major surgery, chemotherapy, radical radiotherapy, investigational agents, or other anticancer therapy
Major surgery, chemotherapy, radical radiotherapy, investigational agents, or other anticancer therapy in the last 4 weeks before treatment start.
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L (> 2 weeks off growth factors); platelets ≥ 100 x 10^9/L; hemoglobin ≥ 9 g/dl without transfusions in last 2 weeks
Kidney function
eGFR > 50 ml/min/1.73 m2 (CKD-EPI formula)
Liver function
total bilirubin < 1.5 x ULN; ALT/AST < 3 x ULN (< 5 x ULN with hepatic metastases)
Cardiac function
LVEF ≥ 50% by echocardiography or MUGA
Adequate bone marrow function... Adequate hepatic function... Adequate renal function... Baseline left ventricular ejection fraction (LVEF) < 50% by echocardiography or multi-gated scintigraphic scan (MUGA) [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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