OncoMatch/Clinical Trials/NCT06755450
Study Evaluating Safety Pharmacokinetics and Pharmacodynamics of AUR112 in Patients With Relapsed Advanced Lymphoma
Is NCT06755450 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies AUR112 for relapsed advanced lymphomas.
Treatment: AUR112 — 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)
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — NHL, CLL, or Hodgkin disease
patients must have relapsed or refractory to at least 2 prior lines of systemic therapies for NHL or CLL, or Hodgkin disease
Cannot have received: systemic anti-cancer therapy
Exception: Concomitant use of low dose prednisone (up to 10 mg/day) is allowed
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
Cannot have received: definitive radiotherapy
Exception: limited field palliative radiation is allowed
Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed)
Cannot have received: investigational agent
Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1
Cannot have received: major surgery
Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia)
Lab requirements
Blood counts
ANC ≥ 1000/μL (without WBC growth factor support); Platelet count: For CLL ≥ 50,000/μL; For lymphomas ≥ 75,000/μL without bone marrow involvement and ≥ 50,000/μL with bone marrow involvement (without platelet transfusion support); Hemoglobin ≥ 9 g/dL (RBC transfusion allowed)
Kidney function
Creatinine clearance (CrCl) ≥ 60 mL/min (either measured or estimated by the Cockcroft-Gault formula)
Liver function
Total Bilirubin ≤ 1.5 x ULN (≤ 2.5 x ULN if Gilbert's syndrome); AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases); ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
Cardiac function
QTcF (Fridericia) interval >470 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose [excluded]; Uncontrolled congestive heart failure (NYHA Class 2-4), angina, MI, CVA, CABG, TIA, or PE within 3 months prior to Cycle 1 Day 1 [excluded]; Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in past 3 months, before Cycle 1 Day 1 [excluded]
Acceptable bone marrow and organ function at screening as described below
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify