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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT05865002 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 IV is required (metastatic disease required).
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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