An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
Males or females ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
ANC ≥ 1000/μL (without WBC growth factor support)
Platelet count ≥ 75,000/μL without transfusion support
Systemic anti-cancer therapy, such as chemotherapy, or biological therapy, immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from the Cycle 1 Day 1 of the study.
Presence of an 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 any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
Sequential
AUR108
Drug3 Days dosing, and 4 days no dose in a week
1. First cycle Dose Limiting Toxicities (DLT)
Assess dose limiliting toxicities of AUR108
Safety of AUR108 as measured by the number of participants with treatment-related adverse events (AE) graded according to NCI CTCAE version 5.0
Number of participants with TEAEs
Pharmacokinetics Maximum Concentration (Cmax)
Maximum Concentration of AUR108
Pharmacokinetics: Time to Maximum concentration (Tmax)
Tmax in hours
PD biomarker assessment
Change from baseline in biomarker (DHO) levels
Overall Response Rate
Efficacy assessments by Overall Response Rate
Duration of Response
Efficacy assessments by Duration of Response
Progression Free Survival
Efficacy assessments by Progression Free Survival (PFS)
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