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