Safety, Tolerability, and Pharmacokinetics of EVT801 in Patients With Advanced Solid Tumours (NCT05114668) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, and Pharmacokinetics of EVT801 in Patients With Advanced Solid Tumours
France32 participantsStarted 2021-11-03
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MTD and / or a RP2D of EVT801 when administered daily to subjects with advanced or metastatic solid tumours.
. 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:
Exclusion criteria
. 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.
. 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.
. Clinically significant cardiac disease or impaired cardiac function, including:
. 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).