An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced malignancies will be done to assess AUR107 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
Males and females ≥ 18 years of age.
Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
ANC ≥ 1500/μL (without WBC growth factor support)
Platelet count ≥ 100,000/μL without transfusion support
Systemic anti-cancer therapy, such as chemotherapy, biological therapy, or immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from Cycle 1 Day 1 of the study.
Presence of acute or chronic toxicity resulting from prior anticancer treatment, with the exception of alopecia or nail changes, that has not resolved to Grade ≤ 1, as determined by NCI CTCAE v 5.0.
Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial)
Use of drugs which are moderate / strong CYP3A4 inducers and/or drugs which are predominantly metabolized by CYP3A4 within 1week or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
Sequential
AUR107
DrugOnce daily
First cycle Dose Limiting Toxicities (DLT)
Assess dose limiliting toxicities of AUR107
Safety of AUR107 as measured by the number of participants with treatment-related adverse events (AE) graded according to NCI CTCAE version 5.0
The assessment of safety was based on the frequency of deaths, AEs, SAEs, AEs leading to discontinuation of study drug, and abnormalities in specific clinical laboratory assessments. AEs and laboratory values will be graded for severity according to the NCI CTCAE version 5.0.
Optimal Biological Dose
Determine optimal Biological dose
Pharmacokinetics: Maximum concentration (Cmax)
Maximum concentration of AUR107
Exploratory endpoint: Identification of gene expression profiles
Pharmacodynamic marker: Gene Expression profile as assessed by RNA analysis
Exploratory endpoint- Efficacy assessments, Overall Response Rate
Efficacy assessments-Overall Response Rate
Exploratory endpoint- Efficacy assessments, Duration of Response
Efficacy assessments- Duration of Response
Exploratory endpoint- Efficacy assessments, Progression Free Survival (PFS)
Efficacy assessments- Progression Free Survival (PFS)
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