Clinical Trials Logo

Clinical 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 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05114668
Study type Interventional
Source Kazia Therapeutics Limited
Contact James S Garner, MBBS
Phone +61 491 220 560
Email [email protected]
Status Recruiting
Phase Phase 1
Start date November 3, 2021
Completion date October 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04551885 - FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors Phase 1
Recruiting NCT05054348 - Dose Escalation Study of IO-108 and IO-108+Pembrolizumab in Solid Tumors Phase 1
Recruiting NCT04474470 - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer Phase 1/Phase 2
Recruiting NCT04020185 - Safety and Efficacy Study of IMSA101 in Refractory Malignancies Phase 1/Phase 2
Not yet recruiting NCT05055609 - Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors Phase 1
Recruiting NCT04526106 - First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors Phase 1
Recruiting NCT04552288 - Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies Phase 2
Recruiting NCT04121442 - Isunakinra Alone and in Combination With a PD-1/PD-L1 Inhibitor in Patients With Solid Tumors Phase 1/Phase 2
Recruiting NCT04221204 - A Monotherapy in Subjects With Advanced Solid Tumors Phase 1
Terminated NCT03992326 - Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes in Solid Tumors Phase 1
Recruiting NCT04981119 - Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Leukapheresis for CAR T- Cell Manufacturing
Recruiting NCT04092673 - Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies Phase 1/Phase 2
Recruiting NCT04899505 - Evaluation of the Impact of Chemotherapy on Body Odor in Adolescents and Young Adults in Oncology
Recruiting NCT04130516 - Phase 1 Study to Determine the MTD, Safety, Tolerability, PK and Preliminary Anti-tumor Effects of LNS8801alone and With Pembrolizumab Phase 1/Phase 2
Active, not recruiting NCT04041310 - Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT04597541 - A Study of AK112, a PD-1/VEGF Bispecific Antibody, for Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04585035 - Study to Evaluate D-1553 in Subjects With Solid Tumors Phase 1/Phase 2
Recruiting NCT04165330 - Evaluation of AL3818 in Combination With Nivolumab in Solid Tumors Phase 1/Phase 2
Completed NCT04515043 - EXPLORATORY STUDY Addendum to INVAC1-CT-101 (NCT02301754) Phase 1
Recruiting NCT03600090 - Phase I Study of EOC202 Plus Paclitaxel in Chinese Patients With Metastatic Breast Cancer Phase 1