Solid Tumor, AdultPhase 1NCT05114668
Safety, Tolerability, and Pharmacokinetics of EVT801 in Patients With Advanced Solid Tumours
A Phase 1 study testing EVT801 in people with Solid Tumor, Adult, run by Kazia Therapeutics Limited at 2 sites in France.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of EVT801 in subjects with advanced or metastatic solid tumours. The study also aims to determine the maximum tolerated dose (MTD) and / or a recommended Phase 2 dose (RP2D) of EVT801 when administered daily to subjects with advanced or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- EVT801
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Nov 2021to 22 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of any gender who are ≥18 years of age at the time of study entry.
- Histologically-confirmed advanced or metastatic solid tumours, unresponsive to standard treatment, or for whom no standard treatment is available or appropriate.
- Measurable or evaluable disease per RECIST 1.1 criteria.
- ECOG performance status <2.
- Life expectancy of greater than 3 months, in the opinion of the investigator.
- Able and willing to provide archived tumour samples, or to undergo pre-treatment tumour biopsy if feasible; subjects must be able to provide at least one tumour tissue sample (archived or pre-treatment biopsy) to be eligible.
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- Written, signed, and dated informed consent to participate in this study in a format approved by the ethics committee.
- Adequate organ and bone marrow function at the time of screening, including:
- Haematology:
- Absolute neutrophil count (ANC) >1.5 x 109/L.
- Platelet count of >75 x 109/L.
- Haemoglobin > 90g/L (without transfusion for at least 2 weeks).
- Renal Function:
- Estimated glomerular filtration rate (GFR), based on MDRD (modification of diet in renal disease) calculation, of ≥60 ml/min/1.73 m2.
- Creatinine ≤1.5 mg/dL (≤132.6 μmol/L).
- Urine dipstick for proteinuria <2+. Subjects discovered to have ≥2+ proteinuria on dipstick urinalysis should undergo a 24-hour urine collection and must demonstrate ≤1.0 g of protein in 24 hours OR Urine protein/creatinine ratio ≤1.0.
- Liver Function:
- Total bilirubin ≤1.5 x ULN (<2 x ULN for subjects with suspected Gilbert's syndrome).
- AST and ALT <2.5 x ULN (<5 x ULN if liver metastases are present).
- Alkaline phosphatase <3 x ULN (<5 x ULN if liver or bone metastases are present).
- Coagulation:
- Prothrombin time (PT) <1.5 x ULN.
- Partial thromboplastin time (PTT) <1.5 x ULN.
- International normalised ratio (INR) <1.5 x ULN (or within target range if on prophylactic anticoagulation therapy).
- The effects of EVT801 on the developing human foetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (e.g. hormonal or barrier method of birth control) prior to study entry and for the duration of study participation and for a period of 6 months after the last dose of study medication; female subjects will be required to demonstrate a negative serum pregnancy test prior to study entry and subjects who are lactating should be excluded. Fertile men (as defined in section 5.5) must agree to use adequate contraception up to 90 days after the last dose of EVT801 according to the latest version of the CTFG Contraception Guidance.
- Able and willing, in the judgment of the investigator, to meet all protocol-required treatments, investigations and visits. This must include the ability for the subject to comply with daily self-administration of an oral therapy, or reliable means for treatment to be administered by a dependable third party such as a relative or caregiver. Subjects must also be able and willing to undergo magnetic resonance imaging, and to receive gadolinium-containing contrast media.
- Additional Inclusion Criteria for Stage 2:
- Subjects with a histologically confirmed diagnosis of advanced renal cell carcinoma (Stage 2A) or advanced soft tissue sarcoma (Stage 2B).
- Subjects who are suitable and willing to provide two biopsies of tumour tissue (pre-treatment and on-treatment).
Who cannot join
- Recent history of antitumor therapy administered with the intent of treating cancer prior to study entry, including pharmacological agents, surgical procedures, or radiotherapy; symptomatic treatments such as analgesia or steroids are permitted; palliative radiotherapy is permitted, providing it is completed at least two weeks prior to study entry. Exclusion period will be adapted to the previous line of therapy: 6 weeks for nitrogen mustard type alkylating agents, 4 weeks for monoclonal antibodies, 3 weeks for standard chemotherapy and 2 weeks or 5 half-lives for small molecule targeted agents and hormonal therapy.
- Any unresolved toxicity from prior treatment of Grade ≥2, according to NCI CTCAE version 5.0, except for alopecia, vitiligo, supplemented and stable endocrine disorders following immuno-oncology treatment or abnormal laboratory parameters within the ranges defined in the inclusion criteria.
- Subjects with Grade ≥2 neuropathy, and subjects with irreversible toxicity that is not reasonably expected to be exacerbated by study participation, may be included only after consultation with the lead investigator.
- CNS tumours: symptomatic or steroid-dependent lesions. Cured lesions are acceptable.
- History of another primary malignancy, unless treated with curative intent and with no known active disease for ≥2 years prior to study entry; subjects with a history of adequately treated non-melanoma skin cancer or superficial bladder cancer or carcinoma in situ of the cervix may be enrolled if there is no evidence of residual disease.
- Current participation in another interventional clinical trial, or participation within 28 days prior to study entry.
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- Clinically significant cardiac disease or impaired cardiac function, including:
- Congestive heart failure requiring treatment (New York Heart Association (NYHA) Grade ≥2).
- Left ventricular ejection fraction (LVEF) <50%, as determined by MUGA scan or echocardiogram.
- History or current evidence of clinically significant or uncontrolled cardiac arrhythmias, atrial fibrillation, or conduction abnormality.
- Acute coronary syndromes, myocardial infarction, unstable angina, or procedures including coronary artery bypass grafting (CABG) or coronary angioplasty within 6 months prior to screening.
- Uncontrolled hyperkalemia.
- Mean (based on mean value of screening triplicate ECGs) resting corrected QT interval (QTc) > 470 msec (for women) and > 450 msec (for men) obtained from 3 consecutive ECGs or with QT interval > 500 msec for one of the ECGs at screening visit and D1 predose.
- Any disease of the GI tract which renders the subject unable to take oral medications, or which might affect the absorption of oral medicines (e.g. inflammatory bowel disease, malabsorption syndrome, requirement for parenteral nutrition).
- Active haemorrhagic syndrome, or presence of tumour in contact with large vessels (e.g. neck, mediastinum, retroperitoneum).
- Acute infection within 1 week prior to starting study treatment.
- Diagnosis of SARS-CoV-2, confirmed by PCR within 3 months prior to starting study treatment, unless fully resolved with no residual symptoms.
- Known active infection including hepatitis B (HbsAg positive), hepatitis C, or HIV are not eligible; subjects with treated HBV or HCV infection with negative or stable PCR for HBV or HCV RNA are eligible; subjects with resolved HBV infection (anti-HBc positive and HBsAg negative) are eligible; subjects with HCV antibodies are eligible if negative PCR for HCV RNA.
- Any pre-existing or intercurrent illness or pathology which, in the judgment of the investigator, has the potential to increase the safety risk associated with EVT801 administration, or to confound the results of the study.
- History of severe allergic reactions to any unknown allergens or to any components of the study drug or to any other VEGFR3 inhibitor.
- Subjects receiving any medications or substances that are moderate and/or potent CYP3A4 inhibitors which may have an effect on the metabolism of EVT801 should be excluded.
- Subjects not covered by a healthcare insurance system.
- Subjects deprived of liberty by a judicial or administrative decision, patient admitted to a social institution or who is under a measure of legal protection, patient hospitalized without consent or who is in an emergency situation.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Léon Bérard
Lyon, 69373
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, 31059
About this study
Official title: A Phase 1, First-in-Human, Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of EVT801 in Patients With Advanced Solid Tumours
The main purpose of this study is to evaluate the safety and tolerability of EVT801 in subjects with advanced or metastatic solid tumours. The study also aims to determine the maximum tolerated dose (MTD) and / or a recommended Phase 2 dose (RP2D) of EVT801 when administered daily to subjects with advanced or metastatic solid tumours.
The study comprises two stages, each with distinct purposes, patient populations, and procedures:
- Stage 1: a multiple ascending dose escalation of EVT801 to evaluate the safety and tolerability of EVT801 and to determine MTD / RP2D in subjects with advanced solid tumours.
- Stage 2: a biomarker expansion cohort, in which all subjects will receive EVT801 at the MTD / RP2D, to explore pharmacodynamic outcomes and further elucidate tolerability, activity, and pharmacokinetics.
Read the detailed description
Stage 1 - Dose Escalation Cohorts:
Stage 1 is a multiple ascending dose escalation of EVT801 in patients with advanced solid tumours to determine MTD / RP2D for further investigation.
After completing screening and signing informed consent, subjects will be enrolled. The first dose of study drug will be administered at the site, and patients will undergo intensive PK assessment for 48 hours before receiving the second and subsequent doses.
The first subject in Stage 1 will receive EVT801 at a dose of 50 mg QD (Quaque Die: once daily) (Dose Level 1). If no Doses Limiting Toxicity (DLTs) are observed in a 28-day period, the second subject may be enrolled at Dose Level 2. The study will proceed by way of single-patient cohorts until (a) treatment-related toxicity of at least Grade 2 is observed, or (b) Dose Level 5 is reached, or (c) the Principal Investigator, in consultation with the sponsor, determines that it is appropriate to transition to larger cohorts. At this point, the study will move to a conventional 3+3 design.
If a DLT is observed in any cohort, that cohort will expand to six patients. If two DLTs are observed at a given dose level, the prior dose level will be declared the MTD, and Stage 1 will be deemed complete. If the prior dose level had recruited only a single patient, then that dose level will be expanded to three patients, such that the MTD will have been administered to a minimum of three patients.
If two DLTs are observed at Dose Level 2 (100 mg QD), a de-escalation cohort (Dose Level -1) will enrol three patients in order to establish the viability of twice-daily dosing.
Once the MTD has been established, the sponsor will evaluate, in consultation with the investigators, whether that dose or a lower dose should be used for subsequent investigation (the RP2D). This evaluation will be based on a consideration of broader factors than safety, including PK and PD. The RP2D shall under no circumstances be greater than the MTD.
The sequence of doses examined will be:
50 mg QD → 100 mg QD (→50 mg BID [Bis In Die (i.e. twice daily)] if 2 DLTs / 6 patients @ 100 mg QD) → 100 mg BID → 200 mg BID → 400 mg BID → 500 mg BID → 600 mg BID → 800 mg BID (up to 8 cohorts).
After completion of at least two cycles at the dose level to which they were initially assigned, individual subjects may escalate to higher dose levels, providing the higher dose level has (a) been administered to at least one patient for at least 28 days without grade 2 treatment-related toxicity, or (b) been administered to at least three subjects for at least 28 days without a DLT, or (c) been administered to at least six subjects for at least 28 days with no more than one DLT. A given subject may escalate through multiple dose levels in this fashion, providing the aforementioned criteria continue to be satisfied and the patient has no ongoing clinically significant adverse event > grade 1.
Stage 2 - Biomarker Expansion Cohorts:
Immediately following determination of the MTD / RP2D in Stage 1, Stage 2 will open to recruitment.
Stage 2 comprises two sub-components:
- Stage 2A :patients with advanced renal cell carcinoma.
- Stage 2B: patients with advanced soft-tissue sarcoma. Subjects may be enrolled in parallel, as they become available through screening.
All subjects in Stage 2 will receive EVT801 at the MTD / RP2D established in Stage 1.
- Conditions
- Solid Tumor, Adult
- Being tested
- EVT801
- Keywords
- cancer, solid tumors, advanced or metastatic tumors, renal cell carcinoma, soft tissue sarcoma
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Carcinoma, Renal Cell, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVT801Drug
Stage 1: Patients will be dosed orally with EVT801 capsules at the dose and schedule to which they are assigned.
Stage 2: Patients will be dosed orally with EVT801 capsules at the MTD / RP2D identified in Stage 1 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 | Experimental | - Stage 1 (Dose Escalation Cohorts): Stage 1 is a multiple ascending dose escalation of EVT801 in patients with advanced solid tumours to evaluate the safety and tolerability of EVT801 and to determine MTD / RP2D for further investigation. Receives: Drug: EVT801 |
| Stage 2 | Experimental | - Stage 2 (Biomarker Expansion cohorts): A biomarker expansion cohort, in which all subjects will receive EVT801 at the MTD / RP2D, will be recruited to explore pharmacodynamic outcomes and further elucidate tolerability, activity, and pharmacokinetics. Receives: Drug: EVT801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD and / or a RP2D of EVT801 when administered daily to subjects with advanced or metastatic solid tumours.
The MTD is defined as the highest dose administered at which fewer than one-third of patients experienced a DLT.
The RP2D will be determined for Stage 1 on the basis of an overall assessment of safety, pharmacokinetics, and other information. The RP2D may be equal to, or lower than, the MTD.
Measured: 24 months
Adverse event (AE) safety information for EVT801
To provide safety information for EVT801 by assessing adverse events, per CTCAE v5.0.
Measured: 36 months
Secondary outcomes (6)
Cmax pharmacokinetic (PK) parameter of EVT801 following administration in an oral capsule formulation.
Measured: 12 months
Tmax pharmacokinetic (PK) parameter of EVT801 following administration in an oral capsule formulation.
Measured: 12 months
T1/2 pharmacokinetic (PK) parameter of EVT801 following administration in an oral capsule formulation.
Measured: 12 months
AUC(0-last) and AUC(0-inf) pharmacokinetic (PK) parameter of EVT801 following administration in an oral capsule formulation.
Measured: 12 months
CL pharmacokinetic (PK) parameter of EVT801 following administration in an oral capsule formulation.
Measured: 12 months
Preliminary anti-tumour activity of EVT801 via assessment of overall response rate (ORR).
ORR will be defined as the proportion of patients in a given analysis population that demonstrate a best overall response of Complete Response (CR) or Partial Response (PR), based on investigator assessment using RECIST (v1.1) criteria
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start3 Nov 2021
- Primary completion4 Nov 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kazia Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Gomez-Roca, MD, Principal investigator, Institut Claudius Regaud, Toulouse, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114668
- Sponsor's protocol ID
- KZA-0801-101
- Status last verified
- Aug 2025
- First submitted
- 6 Oct 2021
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of EVT801 in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT05114668
- Acronym / sponsor ID
- KZA-0801-101
- Conditions
- Solid Tumor, Adult
- Keywords
- cancer, solid tumors, advanced or metastatic tumors, renal cell carcinoma, soft tissue sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kazia Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 10 Nov 2021 (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 main purpose of this study is to evaluate the safety and tolerability of EVT801 in subjects with advanced or metastatic solid tumours. The study also aims to determine the maximum tolerated dose (MTD) and / or a recommended Phase 2 dose (RP2D) of EVT801 when administered daily to subjects with advanced or metastatic solid tumours.
The study comprises two stages, each with distinct purposes, patient populations, and procedures:
- Stage 1: a multiple ascending dose escalation of EVT801 to evaluate the safety and tolerability of EVT801 and to determine MTD / RP2D in subjects with advanced solid tumours.
- Stage 2: a biomarker expansion cohort, in which all subjects will receive EVT801 at the MTD / RP2D, to explore pharmacodynamic outcomes and further elucidate tolerability, activity, and pharmacokinetics.
Detailed description
Stage 1 - Dose Escalation Cohorts:
Stage 1 is a multiple ascending dose escalation of EVT801 in patients with advanced solid tumours to determine MTD / RP2D for further investigation.
After completing screening and signing informed consent, subjects will be enrolled. The first dose of study drug will be administered at the site, and patients will undergo intensive PK assessment for 48 hours before receiving the second and subsequent doses.
The first subject in Stage 1 will receive EVT801 at a dose of 50 mg QD (Quaque Die: once daily) (Dose Level 1). If no Doses Limiting Toxicity (DLTs) are observed in a 28-day period, the second subject may be enrolled at Dose Level 2. The study will proceed by way of single-patient cohorts until (a) treatment-related toxicity of at least Grade 2 is observed, or (b) Dose Level 5 is reached, or (c) the Principal Investigator, in consultation with the sponsor, determines that it is appropriate to transition to larger cohorts. At this point, the study will move to a conventional 3+3 design.
If a DLT is observed in any cohort, that cohort will expand to six patients. If two DLTs are observed at a given dose level, the prior dose level will be declared the MTD, and Stage 1 will be deemed complete. If the prior dose level had recruited only a single patient, then that dose level will be expanded to three patients, such that the MTD will have been administered to a minimum of three patients.
If two DLTs are observed at Dose Level 2 (100 mg QD), a de-escalation cohort (Dose Level -1) will enrol three patients in order to establish the viability of twice-daily dosing.
Once the MTD has been established, the sponsor will evaluate, in consultation with the investigators, whether that dose or a lower dose should be used for subsequent investigation (the RP2D). This evaluation will be based on a consideration of broader factors than safety, including PK and PD. The RP2D shall under no circumstances be greater than the MTD.
The sequence of doses examined will be:
50 mg QD → 100 mg QD (→50 mg BID [Bis In Die (i.e. twice daily)] if 2 DLTs / 6 patients @ 100 mg QD) → 100 mg BID → 200 mg BID → 400 mg BID → 500 mg BID → 600 mg BID → 800 mg BID (up to 8 cohorts).
After completion of at least two cycles at the dose level to which they were initially assigned, individual subjects may escalate to higher dose levels, providing the higher dose level has (a) been administered to at least one patient for at least 28 days without grade 2 treatment-related toxicity, or (b) been administered to at least three subjects for at least 28 days without a DLT, or (c) been administered to at least six subjects for at least 28 days with no more than one DLT. A given subject may escalate through multiple dose levels in this fashion, providing the aforementioned criteria continue to be satisfied and the patient has no ongoing clinically significant adverse event > grade 1.
Stage 2 - Biomarker Expansion Cohorts:
Immediately following determination of the MTD / RP2D in Stage 1, Stage 2 will open to recruitment.
Stage 2 comprises two sub-components:
- Stage 2A :patients with advanced renal cell carcinoma.
- Stage 2B: patients with advanced soft-tissue sarcoma. Subjects may be enrolled in parallel, as they become available through screening.
All subjects in Stage 2 will receive EVT801 at the MTD / RP2D established in Stage 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1 | Experimental | Drug: EVT801- Stage 1 (Dose Escalation Cohorts): Stage 1 is a multiple ascending dose escalation of EVT801 in patients with advanced solid tumours to evaluate the safety and tolerability of EVT801 and to determine MTD / RP2D for further investigation. |
| Stage 2 | Experimental | Drug: EVT801- Stage 2 (Biomarker Expansion cohorts): A biomarker expansion cohort, in which all subjects will receive EVT801 at the MTD / RP2D, will be recruited to explore pharmacodynamic outcomes and further elucidate tolerability, activity, and pharmacokinetics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Subjects of any gender who are ≥18 years of age at the time of study entry.
- Histologically-confirmed advanced or metastatic solid tumours, unresponsive to standard treatment, or for whom no standard treatment is available or appropriate.
- Measurable or evaluable disease per RECIST 1.1 criteria.
- ECOG performance status <2.
- Life expectancy of greater than 3 months, in the opinion of the investigator.
Key exclusion criteria (23 listed)
- Recent history of antitumor therapy administered with the intent of treating cancer prior to study entry, including pharmacological agents, surgical procedures, or radiotherapy; symptomatic treatments such as analgesia or steroids are permitted; palliative radiotherapy is permitted, providing it is completed at least two weeks prior to study entry. Exclusion period will be adapted to the previous line of therapy: 6 weeks for nitrogen mustard type alkylating agents, 4 weeks for monoclonal antibodies, 3 weeks for standard chemotherapy and 2 weeks or 5 half-lives for small molecule targeted agents and hormonal therapy.
- Any unresolved toxicity from prior treatment of Grade ≥2, according to NCI CTCAE version 5.0, except for alopecia, vitiligo, supplemented and stable endocrine disorders following immuno-oncology treatment or abnormal laboratory parameters within the ranges defined in the inclusion criteria.
- Subjects with Grade ≥2 neuropathy, and subjects with irreversible toxicity that is not reasonably expected to be exacerbated by study participation, may be included only after consultation with the lead investigator.
- CNS tumours: symptomatic or steroid-dependent lesions. Cured lesions are acceptable.
- History of another primary malignancy, unless treated with curative intent and with no known active disease for ≥2 years prior to study entry; subjects with a history of adequately treated non-melanoma skin cancer or superficial bladder cancer or carcinoma in situ of the cervix may be enrolled if there is no evidence of residual disease.
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 |
|---|---|---|
| EVT801Stage 1: Patients will be dosed orally with EVT801 capsules at the dose and schedule to which they are assigned. Stage 2: Patients will be dosed orally with EVT801 capsules at the MTD / RP2D identified in Stage 1 of the study. | Drug | Stage 1, Stage 2 |
Primary outcome
MTD and / or a RP2D of EVT801 when administered daily to subjects with advanced or metastatic solid tumours.
Time frame: 24 months
The MTD is defined as the highest dose administered at which fewer than one-third of patients experienced a DLT. The RP2D will be determined for Stage 1 on the basis of an overall assessment of safety, pharmacokinetics, and other information. The RP2D may be equal to, or lower than, the MTD.
Adverse event (AE) safety information for EVT801
Time frame: 36 months
To provide safety information for EVT801 by assessing adverse events, per CTCAE v5.0.
6 secondary outcomes
Cmax pharmacokinetic (PK) parameter of EVT801 following administration in an oral capsule formulation.
Time frame: 12 months
Tmax pharmacokinetic (PK) parameter of EVT801 following administration in an oral capsule formulation.
Time frame: 12 months
T1/2 pharmacokinetic (PK) parameter of EVT801 following administration in an oral capsule formulation.
Time frame: 12 months
AUC(0-last) and AUC(0-inf) pharmacokinetic (PK) parameter of EVT801 following administration in an oral capsule formulation.
Time frame: 12 months
CL pharmacokinetic (PK) parameter of EVT801 following administration in an oral capsule formulation.
Time frame: 12 months
Preliminary anti-tumour activity of EVT801 via assessment of overall response rate (ORR).
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
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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.
Carlos Gomez-Roca, MD principal investigator
Institut Claudius Regaud, Toulouse, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EVT801 in people with Solid Tumor, Adult, run by Kazia Therapeutics Limited at 2 sites in France.
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 29 inclusion and 23 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: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MTD and / or a RP2D of EVT801 when administered daily to subjects with advanced or metastatic solid tumours. (time frame: 24 months). 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 2 Sep 2025.