A Phase 1, Open Label, Dose Escalation, Multicenter, First-in-Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR112 in Patients with Relapsed Advanced Lymphoma (ADITI-1)
Males and 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: For patients with CLL ≥ 50,000/μL; For patients with lymphomas ≥ 75,000/μL without bone marrow involvement and ≥ 50,000/μL with bone marrow involvement. These thresholds should be qualified without platelet 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 the Cycle 1 Day 1 of the study. Note: Concomitant use of low dose prednisone (up to 10 mg/day) is allowed
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. 1
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
AUR112
DrugOnce daily
First cycle Dose Limiting Toxicities (DLT).
Number of participants with dose limiting toxicities (DLT) taking AUR112
Safety of AUR112 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, adverse event (AE), serious adverse event (SAE)s leading to discontinuation of study drug, and abnormalities in specific laboratory assessments. AEs and laboratory values will be graded for severity according to NCI CTCAE version 5.0
To determine the doses to be recommended for evaluation in future studies.
Determine selected dose(s) to be studied in future clinical trials
Pharmacokinetics: Maximum concentration (Cmax)
Maximum concentration of AUR112
Exploratory endpoint: Expression of cytokines
Pharmacodynamic marker: CYTOKINE MARKERS analysis
Exploratory endpoint: Gene expression profile
Pharmacodynamic marker: Gene expression analysed from whole blood
Exploratory endpoint- Efficacy assessments, Overall Response Rate
Efficacy assessments-Overall Response Rate
Exploratory endpoint- Efficacy assessments, Duration of Response
Efficacy assessments- Duration of Response
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