OncoMatch/Clinical Trials/NCT05984147
A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)
Is NCT05984147 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies AUR108 for relapsed advanced lymphomas.
Treatment: AUR108 — 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.
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
At a minimum, the patients must have received at least 2 prior lines of systemic therapies. These systemic therapies could be either in the stage II, III or IV.
Cannot have received: systemic anti-cancer therapy (chemotherapy, biological therapy, immunomodulatory drug therapy)
Exception: allowed if >28 days or >5 half-lives from Cycle 1 Day 1
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.
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 and no restrictions during the screening period or during the trial).
Cannot have received: investigational agent
Exception: allowed if >28 days or >5 half-lives from Cycle 1 Day 1
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
Exception: allowed if >28 days from Cycle 1 Day 1
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 ≥ 75,000/μL without transfusion support; Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)
Kidney function
Creatinine clearance (CrCl) ≥ 30 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
QTc (Bazzett) interval >460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose [excluded]
Acceptable bone marrow and organ function at screening as described below: ANC ≥ 1000/μL (without WBC growth factor support); Platelet count ≥ 75,000/μL without transfusion support; Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb); Total Bilirubin ≤ 1.5 x ULN; (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN); AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases); ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases); Creatinine clearance (CrCl) ≥ 30 mL/min (either measured or estimated by the Cockcroft-Gault formula). QTc (Bazzett) interval >460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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