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 range18 Years
SexALL
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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.
✓. 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
✕
What they're measuring
1
MTD and / or a RP2D of EVT801 when administered daily to subjects with advanced or metastatic solid tumours.
. 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).