OncoMatch/Clinical Trials/NCT05865002
A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)
Is NCT05865002 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies AUR107 for relapsed malignant solid neoplasm.
Treatment: AUR107 — An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced malignancies will be done to assess AUR107 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — metastatic
solid tumor patients must have received at least two lines of systemic therapies in the metastatic incurable settings
Cannot have received: systemic anti-cancer therapy
Exception: low-dose prednisone (up to 10 mg/day) or medroxyprogesterone allowed; ongoing LHRH analogs for CRPC 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 Cycle 1 Day 1 of the study.
Cannot have received: definitive radiotherapy
Exception: limited field palliative radiation 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
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 ≥ 1500/μL (without WBC growth factor support); Platelet count ≥ 100,000/μL without transfusion support; Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)
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
QTc (Bazzett) interval >460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose [excluded]; Uncontrolled congestive heart failure (NYHA Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3 months prior to Cycle 1 Day 1 [excluded]; Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in the past 3 months, before Cycle 1 Day 1 [excluded]
Acceptable bone marrow and organ function at screening as described below: ANC ≥ 1500/μL (without WBC growth factor support); Platelet count ≥ 100,000/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) ≥ 60 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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