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OncoMatch/Clinical Trials/NCT06755450

Study Evaluating Safety Pharmacokinetics and Pharmacodynamics of AUR112 in Patients With Relapsed Advanced Lymphoma

Is NCT06755450 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies AUR112 for relapsed advanced lymphomas.

Phase 1RecruitingAurigene Discovery Technologies LimitedNCT06755450Data as of Jun 2026Location: India

Treatment: AUR112A 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)

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Extracted eligibility criteria

Treatments studied

Other

AUR112

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 99

Prior therapy

Min 2 prior lines

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.

Frequently asked questions

Is NCT06755450 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior systemic anti-cancer therapy, definitive radiotherapy, investigational agent disqualifies patients from enrollment.

What disease stage is eligible?

Stage III or IV is required.

Is there an age limit?

Yes. Patients must be 99 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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