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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05495295 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior major surgery, chemotherapy, radical radiotherapy, investigational agents, or other anticancer therapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 negative (< 1% of nuclei reacting for ER in IHC) is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR negative (< 1% of nuclei reacting for PgR in IHC) is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, 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) is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages