Malignant TumorPhase 1PhASTNCT05495295
First-in-human Trial of PhOx430, a First-in-class Acetylglucosaminyltransferase V Inhibitor, in Advanced Solid Tumours
A Phase 1 study testing PhOx430 in people with Malignant Tumor and Advanced Solid Tumor, run by Phost'In Therapeutics at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Tumor, Advanced Solid Tumor, Glioblastoma Multiforme
- What is being tested?
- PhOx430
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 18 Jul 2022to 31 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 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.
- Radiologically documented progressive disease after at least one prior treatment for metastatic/advanced disease.
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- Lack of standard effective treatment options.
- Female or male patients of ≥ 18 years and ≤ 80 years
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. For GBM patients: Karnofsky Performance Status ≥ 50%.
- Recovery from acute reversible toxicities of previous treatment to Grade ≤ 1.
- Tumour tissue accessible for repeated biopsies (except GBM patients).
- For GBM patients: stable dose of corticosteroids for > 5 days before the baseline MRI scan.
- For non-GBM patients: Measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST) guideline V1.1 (specifically, no ascites, pleural or pericardial effusions, osteoblastic bone metastases, or carcinomatous lymphangitis of the lung as the only lesion). For GBM patients: Measurable disease as defined by RANO criteria.
- Adequate bone marrow function defined as:
- absolute neutrophil count ≥ 1.5 x 109/L (being > 2 weeks off hematopoietic growth factors),
- platelet count ≥ 100 x 109/L,
- hemoglobin ≥ 9 g/dl without transfusions in the last 2 weeks.
- Adequate hepatic function defined as:
- total bilirubin < 1.5 x the upper limit of normal (ULN),
- ALT /AST (SGPT/SGOT) < 3 x ULN (< 5 x ULN in the presence of known hepatic metastases),
- Adequate renal function defined as estimated glomerular filtration rate (eGFR) of > 50 ml/min/1.73 m2 according to the CKD-EPI formula.
- Adequate coagulation, defined as INR < 1.5 and aPTT < 1.5 × ULN. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
- Written informed consent obtained prior to any trial-specific screening procedures.
- Life expectancy of at least 3 months
- Women of childbearing potential must have a negative serum pregnancy test obtained within 28 days prior to treatment start; in addition, the negative result is to be confirmed by a repeat urine or serum pregnancy test within 72 hours before study treatment start if the screening test was performed earlier.
- Female patients who are not postmenopausal ("postmenopausal" defined as ≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus) must agree to practice a highly effective method of contraception throughout the study for at least 6 months after the last dose of study drug. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl Index of < 1% per year when used consistently and correctly. Sexual abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- Male patients must agree to remain sexually abstinent or use a condom during the treatment period and for at least 90 days after the last dose of study drug.
- Patients must be able to take IMP at home and to properly use the provided dosing device.
Who cannot join
- 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.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the IMP (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome)
- Any other cancer within 3 years prior to enrolment, with the exception of adequately treated carcinoma in situ of the cervix uteri, or adequately treated basal or squamous cell carcinoma of the skin.
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- Significant liver disease, including active viral, alcoholic or other hepatitis and cirrhosis.
- History of HIV infection, active hepatitis B (chronic or acute), or hepatitis C infection. Patients with past or resolved hepatitis B infection (defined as having a negative HBsAg test and positivity for antibodies for hepatitis B core antigen [anti-HBc]) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA
- Severe infections within 4 weeks prior to enrolment.
- Patients with a history of central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and precluding informed consent or adversely affecting compliance with study drug.
- Baseline left ventricular ejection fraction (LVEF) < 50% by echocardiography or multi-gated scintigraphic scan (MUGA)
- Other current severe, uncontrolled systemic disease
- Treatment with CYP3A4/5 inhibitors within 5 drug elimination half-lives before study treatment start and/or inability or unwillingness to avoid such medications during study treatment
- Known hypersensitivity to any study drug components
- Pregnant or lactating women
- Patients deprived from liberty (for patients enrolled in France only)
- Patients who are not affiliated to a social security scheme or are not beneficiaries of such a scheme (for patients enrolled in France only)
- Adults under legal protection or unable to give their informed consent (for patients enrolled in France only)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Italy3 sites
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
IRCCS Ospedale San Raffaele
Milan, 20132
Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia
Reggio Emilia, 42123
About this study
Official title: An Adaptive First-in-human Trial of PhOx430, a First-in-class Acetylglucosaminyltransferase V Inhibitor, in Patients With Advanced Solid Tumours (PhAST 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.
Read the detailed description
The PhAST Trial is a first-in-human clinical trial of the acetylglucosaminyltransferase V inhibitor PhOx430 in patients with advanced solid tumours. The trial includes two parts, a dose escalation phase (part I) which will enroll patients with non-selected tumour types, followed by a cohort expansion phase (part II) in selected tumour types.
POPULATION:
Adult patients with advanced or metastatic solid malignancies with radiologically documented progression on a previous line of treatment and for which effective treatment options do not exist.
DOSE ESCALATION'S PRIMARY OBJECTIVE:
To determine the Maximal Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of PhOx430 in patients with advanced solid tumours
DOSE ESCALATION'S SECONDARY OBJECTIVE:
- to determine the safety and tolerability profile of PhOx430 at increasing dose levels;
- to characterize the pharmacokinetic (PK) profile of PhOx430, including food effect on drug disposition;
- to evaluate the antitumour activity of PhOx430. DOSE ESCALATION'S EXPLORATORY OBJECTIVE:
- to characterize the pharmacodynamics (PD) effect of PhOx430 on blood, urine and tumour samples collected before and after treatment;
- to identify predictive response biomarkers by profiling responsive patterns.
DOSE EXPANSIONS' PRIMARY OBJECTIVE:
To better characterize the safety and tolerability profile of PhOx430 given at the RP2D in three cohorts of patients affected by 1) glioblastoma multiforme (GBM), 2) triple-negative breast cancer, and 3) selected types of solid tumours.
DOSE EXPANSION'S SECONDARY OBJECTIVE:
- to characterize the pharmacokinetic (PK) profile of PhOx430 at the RP2D.
- to evaluate the antitumour activity of PhOx430 in the specific tumour types selected for the dose expansion cohorts. DOSE EXPANSIONS' EXPLORATORY OBJECTIVE:
- to characterize the pharmacodynamic (PD) effect of PhOx430 on blood, urine and tumour samples collected before and after treatment;
- to identify predictive response biomarkers by profiling responsive patterns.
STUDY DESIGN AND TREATMENT PLAN:
Dose Escalation Phase - STEP 1-2: a standard 3 + 3 design will be followed. PhOx430 will be administered orally twice a day (bid), at a 12-hour interval, continuously in cycles of 21 days. At each dose level (DL), at least three patients will be included and the first patient will be observed for at least 21 days before enrolling the following two.
Dose Escalation Phase - STEP 3 (Dosing-optimization Cohort): The implementation of this Dosing-optimization cohort (Step 3) was decided by the Protocol Steering Committee (PSC) based on clinical and pharmacokinetic data obtained in Steps 1 and 2. Six patients will be enrolled, who will be administered a flat dose of PhOx430 (1,200 mg by patients weighing ≥ 50 kg and of 600 mg by patients weighing < 50 kg) orally thrice a day (tid) for 21 days, and then, starting from day 22, four times a day (qid), continuously in cycles of 21 days. The first patient will be observed after treatment start for at least 21 days before enrolling the following two. After the third patient is observed for 21 days after treatment start, three additional patients will be enrolled without waiting time between them. In case the daily dose tested with the tid schedule is not deemed safe, the flat dose of PhOx430 will be tested twice a day (bid).
Cohort Expansion Phase: in the cohort expansion phase, the safety profile of PhOx430 will be further characterized by testing the RP2D in three parallel cohorts of patients affected by glioblastoma multiforme (GBM) (cohort 1), triple-negative breast cancer (TNBC) (cohort 2), and solid tumour types selected by the Protocol Steering Committee (PSC) on the basis of preclinical pharmacological data and of the antitumour activity observed during the Dose Escalation Phase if any (cohort 3), respectively. Cycles will be of 21 days.
ESTIMATED TRIAL DURATION and SAMPLE SIZE:
Dose Escalation Phase Step 1,2,3: approximately 1.5 years Expansion Phase: approximately 1.5 years. The end of trial is defined as 30 days after the last dose of the last enrolled patient.
The following numbers of patients are foreseen: up to 149 patients.
- Being tested
- PhOx430
- Medical subject headings
- Neoplasms, Glioblastoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhOx430Drug
Also called Dose Escalation Phase - STEP 1 and STEP 2
A standard 3 + 3 design will be followed. PhOx430 will be administered orally twice a day (bid), at a 12-hour interval, continuously in cycles of 21 days. At each dose level (DL), three patients will be included and the first patient will be observed for at least 21 days before enrolling the following two. Three additional patients will be enrolled at each DL if a DLT is observed in the first three patients.
A maximum of 4 increasing Dose Levels are foreseen (10, 20, 40 and 70 mg/kg/day), and PhOx430 will be administered in two doses at a 12-hour interval.
PhOx430Drug
Also called Dose Escalation Phase - STEP 3 (Dosing-optimization Cohort)
The implementation of this cohort (Step 3) was decided by the Protocol Steering Committee (PSC) based on clinical and pharmacokinetic data obtained in Steps 1 and 2. Six patients will be enrolled, who will receive PhOx430 orally thrice a day (tid) at a -6-hour interval over 12 hours for 21 days, and then, starting from day 22, four times a day (qid) at a 4-hour interval over 12 hours, continuously in cycles of 21 days. PhOx430 will be taken in single doses of 1,200 mg to patients weighing ≥ 50 kg and of 600 mg to patients weighing < 50 kg, with no requirement for a full or empty stomach. The first patient will be observed after treatment start for at least 21 days before enrolling the following two. After the third patient is observed for 21 days after treatment start, 3 additional patients will be enrolled without waiting time between them. If the daily dose tested with the tid schedule is not deemed safe, the flat dose will be tested twice a day (bid) at a 12-hour interval.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Solid Tumours | Experimental | First-in-human clinical trial of the acetylglucosaminyltransferase V inhibitor PhOx430 in patients with advanced solid tumours. The trial includes two parts, a dose escalation phase (part I) which will enroll patients with non-selected tumour types, followed by a cohort expansion phase (part II) in selected tumour types:
* Glioblastoma Multiforme (GBM)
* Triple Negative Breast Cancer (TNBC)
* Selected solid tumours Receives: Drug: PhOx430 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DOSE ESCALATION PRIMARY OUTCOME (Dose Limiting Toxicities (DLTs))
Dose Limiting Toxicities (DLTs)
Measured: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
DOSE EXPANSION PRIMARY OUTCOME (treatment-emergent Adverse Events)
Incidence, severity and seriousness of treatment-emergent Adverse Events (AEs)
Measured: Through study completion, up to 5 years
Secondary outcomes (9)
DOSE ESCALATION SECONDARY OUTCOME #1 (treatment-emergent Adverse Events)
Incidence, severity and seriousness of treatment-emergent Adverse Events (AEs)
Measured: Through study completion, up to 5 years
DOSE ESCALATION SECONDARY OUTCOME #2 (Plasma concentration levels of PhOx430)
Plasma concentration levels of PhOx430
Measured: During Cycle1 and Cycle 2 (each cycle is 21 days)
DOSE ESCALATION SECONDARY OUTCOME #3 (Objective response rate)
Objective response rate (ORR)
Measured: Through dose escalation completion, an average of 1 year
DOSE EXPANSION SECONDARY OUTCOME #1 (Plasma concentration levels of PhOx430 )
Plasma concentration levels of PhOx430
Measured: During Cycle1 and Cycle 2 (each cycle is 21 days)
DOSE EXPANSION SECONDARY OUTCOME #2 (Objective response rate)
Objective response rate (ORR)
Measured: Through dose expansion completion, an average of 1.5 year
DOSE ESCALATION SECONDARY OUTCOME #4 (progression-free survival)
progression-free survival (PFS)
Measured: Through study completion, up to 5 years
DOSE ESCALATION SECONDARY OUTCOME #5 (overall survival)
overall survival (OS)
Measured: Through study completion, up to 5 years
DOSE EXPANSION SECONDARY OUTCOME #3 (progression-free survival)
progression-free survival (PFS)
Measured: Through study completion, up to 5 years
DOSE EXPANSION SECONDARY OUTCOME #4 ( overall survival)
overall survival (OS)
Measured: Through study completion, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start18 Jul 2022
- Primary completion4 Nov 2024
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- First-in-human clinical trial, including two parts: a dose escalation phase (part I) which will enroll patients with non-selected tumour types, followed by a cohort expansion phase (part II) in selected tumour types.
- Masking
- None (open label)
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phost'In Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alain Herrera, MD, Study director, Phost'In TherapeuticsDiego Tosi, MD, Principal investigator, Institut du Cancer de Montpellier - Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495295
- Sponsor's protocol ID
- PHOX-CLI_001
- Other IDs
- 2021-004170-55
- Acronym
- PhAST
- Status last verified
- Sep 2026
- First submitted
- 27 Jul 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive First-in-human Trial of PhOx430, a First-in-class Acetylglucosaminyltransferase V Inhibitor, in Patients With Advanced Solid Tumours (PhAST Trial)
- ClinicalTrials.gov ID
- NCT05495295
- Acronym / sponsor ID
- PhAST / PHOX-CLI_001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Phost'In TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The PhAST Trial is a first-in-human clinical trial of the acetylglucosaminyltransferase V inhibitor PhOx430 in patients with advanced solid tumours. The trial includes two parts, a dose escalation phase (part I) which will enroll patients with non-selected tumour types, followed by a cohort expansion phase (part II) in selected tumour types.
POPULATION:
Adult patients with advanced or metastatic solid malignancies with radiologically documented progression on a previous line of treatment and for which effective treatment options do not exist.
DOSE ESCALATION'S PRIMARY OBJECTIVE:
To determine the Maximal Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of PhOx430 in patients with advanced solid tumours
DOSE ESCALATION'S SECONDARY OBJECTIVE:
- to determine the safety and tolerability profile of PhOx430 at increasing dose levels;
- to characterize the pharmacokinetic (PK) profile of PhOx430, including food effect on drug disposition;
- to evaluate the antitumour activity of PhOx430. DOSE ESCALATION'S EXPLORATORY OBJECTIVE:
- to characterize the pharmacodynamics (PD) effect of PhOx430 on blood, urine and tumour samples collected before and after treatment;
- to identify predictive response biomarkers by profiling responsive patterns.
DOSE EXPANSIONS' PRIMARY OBJECTIVE:
To better characterize the safety and tolerability profile of PhOx430 given at the RP2D in three cohorts of patients affected by 1) glioblastoma multiforme (GBM), 2) triple-negative breast cancer, and 3) selected types of solid tumours.
DOSE EXPANSION'S SECONDARY OBJECTIVE:
- to characterize the pharmacokinetic (PK) profile of PhOx430 at the RP2D.
- to evaluate the antitumour activity of PhOx430 in the specific tumour types selected for the dose expansion cohorts. DOSE EXPANSIONS' EXPLORATORY OBJECTIVE:
- to characterize the pharmacodynamic (PD) effect of PhOx430 on blood, urine and tumour samples collected before and after treatment;
- to identify predictive response biomarkers by profiling responsive patterns.
STUDY DESIGN AND TREATMENT PLAN:
Dose Escalation Phase - STEP 1-2: a standard 3 + 3 design will be followed. PhOx430 will be administered orally twice a day (bid), at a 12-hour interval, continuously in cycles of 21 days. At each dose level (DL), at least three patients will be included and the first patient will be observed for at least 21 days before enrolling the following two.
Dose Escalation Phase - STEP 3 (Dosing-optimization Cohort): The implementation of this Dosing-optimization cohort (Step 3) was decided by the Protocol Steering Committee (PSC) based on clinical and pharmacokinetic data obtained in Steps 1 and 2. Six patients will be enrolled, who will be administered a flat dose of PhOx430 (1,200 mg by patients weighing ≥ 50 kg and of 600 mg by patients weighing < 50 kg) orally thrice a day (tid) for 21 days, and then, starting from day 22, four times a day (qid), continuously in cycles of 21 days. The first patient will be observed after treatment start for at least 21 days before enrolling the following two. After the third patient is observed for 21 days after treatment start, three additional patients will be enrolled without waiting time between them. In case the daily dose tested with the tid schedule is not deemed safe, the flat dose of PhOx430 will be tested twice a day (bid).
Cohort Expansion Phase: in the cohort expansion phase, the safety profile of PhOx430 will be further characterized by testing the RP2D in three parallel cohorts of patients affected by glioblastoma multiforme (GBM) (cohort 1), triple-negative breast cancer (TNBC) (cohort 2), and solid tumour types selected by the Protocol Steering Committee (PSC) on the basis of preclinical pharmacological data and of the antitumour activity observed during the Dose Escalation Phase if any (cohort 3), respectively. Cycles will be of 21 days.
ESTIMATED TRIAL DURATION and SAMPLE SIZE:
Dose Escalation Phase Step 1,2,3: approximately 1.5 years Expansion Phase: approximately 1.5 years. The end of trial is defined as 30 days after the last dose of the last enrolled patient.
The following numbers of patients are foreseen: up to 149 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- First-in-human clinical trial, including two parts: a dose escalation phase (part I) which will enroll patients with non-selected tumour types, followed by a cohort expansion phase (part II) in selected tumour types.
| Arm | Type | Receives |
|---|---|---|
| Advanced Solid Tumours | Experimental | Drug: PhOx430First-in-human clinical trial of the acetylglucosaminyltransferase V inhibitor PhOx430 in patients with advanced solid tumours. The trial includes two parts, a dose escalation phase (part I) which will enroll patients with non-selected tumour types, followed by a cohort expansion phase (part II) in selected tumour types: * Glioblastoma Multiforme (GBM) * Triple Negative Breast Cancer (TNBC) * Selected solid tumours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Histologically or cytologically confirmed diagnosis of cancer.
- Radiologically documented progressive disease after at least one prior treatment for metastatic/advanced disease.
- Lack of standard effective treatment options.
- Female or male patients of ≥ 18 years and ≤ 80 years
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. For GBM patients: Karnofsky Performance Status ≥ 50%.
Key exclusion criteria (18 listed)
- 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.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the IMP (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhOx430Also: Dose Escalation Phase - STEP 1 and STEP 2A standard 3 + 3 design will be followed. PhOx430 will be administered orally twice a day (bid), at a 12-hour interval, continuously in cycles of 21 days. At each dose level (DL), three patients will be included and the first patient will be observed for at least 21 days before enrolling the following two. Three additional patients will be enrolled at each DL if a DLT is observed in the first three patients. A maximum of 4 increasing Dose Levels are foreseen (10, 20, 40 and 70 mg/kg/day), and PhOx430 will be administered in two doses at a 12-hour interval. | Drug | Advanced Solid Tumours |
| PhOx430Also: Dose Escalation Phase - STEP 3 (Dosing-optimization Cohort)The implementation of this cohort (Step 3) was decided by the Protocol Steering Committee (PSC) based on clinical and pharmacokinetic data obtained in Steps 1 and 2. Six patients will be enrolled, who will receive PhOx430 orally thrice a day (tid) at a -6-hour interval over 12 hours for 21 days, and then, starting from day 22, four times a day (qid) at a 4-hour interval over 12 hours, continuously in cycles of 21 days. PhOx430 will be taken in single doses of 1,200 mg to patients weighing ≥ 50 kg and of 600 mg to patients weighing < 50 kg, with no requirement for a full or empty stomach. The first patient will be observed after treatment start for at least 21 days before enrolling the following two. After the third patient is observed for 21 days after treatment start, 3 additional patients will be enrolled without waiting time between them. If the daily dose tested with the tid schedule is not deemed safe, the flat dose will be tested twice a day (bid) at a 12-hour interval. | Drug | Advanced Solid Tumours |
Primary outcome
DOSE ESCALATION PRIMARY OUTCOME (Dose Limiting Toxicities (DLTs))
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Dose Limiting Toxicities (DLTs)
DOSE EXPANSION PRIMARY OUTCOME (treatment-emergent Adverse Events)
Time frame: Through study completion, up to 5 years
Incidence, severity and seriousness of treatment-emergent Adverse Events (AEs)
9 secondary outcomes
DOSE ESCALATION SECONDARY OUTCOME #1 (treatment-emergent Adverse Events)
Time frame: Through study completion, up to 5 years
DOSE ESCALATION SECONDARY OUTCOME #2 (Plasma concentration levels of PhOx430)
Time frame: During Cycle1 and Cycle 2 (each cycle is 21 days)
DOSE ESCALATION SECONDARY OUTCOME #3 (Objective response rate)
Time frame: Through dose escalation completion, an average of 1 year
DOSE EXPANSION SECONDARY OUTCOME #1 (Plasma concentration levels of PhOx430 )
Time frame: During Cycle1 and Cycle 2 (each cycle is 21 days)
DOSE EXPANSION SECONDARY OUTCOME #2 (Objective response rate)
Time frame: Through dose expansion completion, an average of 1.5 year
DOSE ESCALATION SECONDARY OUTCOME #4 (progression-free survival)
Time frame: Through study completion, up to 5 years
DOSE ESCALATION SECONDARY OUTCOME #5 (overall survival)
Time frame: Through study completion, up to 5 years
DOSE EXPANSION SECONDARY OUTCOME #3 (progression-free survival)
Time frame: Through study completion, up to 5 years
DOSE EXPANSION SECONDARY OUTCOME #4 ( overall survival)
Time frame: Through study completion, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Herrera, MD study director
Phost'In Therapeutics
Diego Tosi, MD principal investigator
Institut du Cancer de Montpellier - Val d'Aurelle
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PhOx430 in people with Malignant Tumor and Advanced Solid Tumor, run by Phost'In Therapeutics at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DOSE ESCALATION PRIMARY OUTCOME (Dose Limiting Toxicities (DLTs)) (time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.