Actively Recruiting
First-in-human Trial of PhOx430, a First-in-class Acetylglucosaminyltransferase V Inhibitor, in Advanced Solid Tumours
Led by Phost'In Therapeutics · Updated on 2025-04-08
149
Participants Needed
4
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
First-in-human Trial of PhOx430, a First-in-class Acetylglucosaminyltransferase V Inhibitor, in Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of cancer.
- Patients with any solid tumor type or histology for dose escalation phase.
- Patients with glioblastoma multiforme (GBM) for expansion cohort 1.
- Patients with triple-negative breast cancer (TNBC) defined by specific receptor negativity for expansion cohort 2.
- Patients with selected solid tumor types for expansion cohort 3.
- Radiologically documented disease progression after at least one prior treatment for metastatic or advanced disease.
- No standard effective treatment options available.
- Age between 18 and 80 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; for GBM patients, Karnofsky Performance Status ≥ 50%.
- Recovery from acute reversible toxicities of prior treatment to Grade ≤ 1.
- Accessible tumor tissue for repeated biopsies, except for GBM patients.
- For GBM patients: stable corticosteroid dose for more than 5 days before baseline MRI.
- Measurable disease per RECIST v1.1 for non-GBM patients; per RANO criteria for GBM patients.
- Adequate bone marrow, liver, renal, and coagulation function as defined by specific laboratory values.
- Written informed consent obtained.
- Life expectancy of at least 3 months.
- Women of childbearing potential must have negative pregnancy tests and agree to effective contraception during and after the study.
- Male patients must agree to use condoms or remain sexually abstinent during treatment and for 90 days after.
- Ability to take investigational medicinal product (IMP) at home and properly use dosing device.
You will not qualify if you...
- Major surgery, chemotherapy, radical radiotherapy, investigational agents, or other anticancer therapy within 4 weeks before treatment start.
- Active central nervous system (CNS) metastases, except for stable treated cases without recent symptoms.
- For GBM patients: disease progression within 3 months after last radiation therapy.
- Inability or unwillingness to swallow.
- Gastrointestinal conditions that may affect drug absorption such as ulcers or uncontrolled nausea.
- Any other cancer within 3 years except certain treated skin or cervical cancers.
- Significant liver disease including active hepatitis or cirrhosis.
- History of HIV infection or active hepatitis B or C infection, with some exceptions.
- Severe infections within 4 weeks prior to enrollment.
- Significant central nervous system disorders or psychiatric disabilities affecting consent or compliance.
- Baseline heart function with left ventricular ejection fraction below 50%.
- Other severe uncontrolled systemic diseases.
- Treatment with CYP3A4/5 inhibitors shortly before study or unwillingness to avoid during study.
- Known hypersensitivity to study drug components.
- Pregnant or breastfeeding women.
- Patients deprived of liberty or without social security affiliation (for patients enrolled in France only).
- Adults under legal protection or unable to give informed consent (for patients enrolled in France only).
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Institut du Cancer de Montpellier
Montpellier, France, 34298
Actively Recruiting
2
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
3
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
4
Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia
Reggio Emilia, Italy, 42123
Actively Recruiting
Research Team
K
Karine Chorro, Mrs.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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