A Phase I, Open Label, Dose-Escalation, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR106 in Patients with Select Relapsed Advanced Malignancies (JIVAN).
This is a Phase I, Open Label, Dose-Escalation, First in Human (FIH) study in adult patients with select relapsed advanced malignancies. The safety and tolerability of oral AUR106 will be evaluated in patients with selected advanced solid tumors (Non-small cell lung cancer, Gastric cancer, Urothelial cancer, Kidney cancer, Colon cancer and Esophageal cancer), who do not have any available curative or life prolonging treatment options and have exhausted all effective locally available therapies. The traditional 3+3 design for dose escalation will be used to evaluate safety, PK/PD and determine the Optimal Biological Dose (OBD) of AUR106, as a single agent. The Optimal Biological Dose will be selected using a totality of safety, PK and PD data.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Once or twice daily
Omega Hospital
Visakhapatnam, Andhra Pradesh, India
RECRUITINGUnique Hospital Multispeciality and Research Institute
Surat, Gujarat, India
RECRUITINGKiran Multi Super Specialty Hospital
Surat, Gujarat, India
RECRUITINGSankalp Speciality Hospital
Nashik, Maharashtra, India
RECRUITINGMoraya Multispeciality Hospital (Ashwin Medical Foundations)
Pune, Maharasthra, India
NOT_YET_RECRUITINGAll India Institute of Medical Sciences
Bhubaneswar, Odisha, India
RECRUITINGOptimal Biological Dose (OBD)
To determine the Optimal Biological Dose (OBD) based on safety, pharmacokinetic, and pharmacodynamic data
Time frame: First 28 Days (Cycle 1)
Dose Limiting Toxicity (DLT)
To determine the DLT of AUR106
Time frame: First 28 Days (Cycle 1)
Pharmacokinetics: Area under the curve (AUC)
Area under the curve of AUR106
Time frame: Day 1 and Day 15
Pharmacokinetics: Maximum concentration Pharmacokinetics: Maximum concentration
Maximum concentration of AUR106
Time frame: Day 1 and Day 15
Pharmacokinetics: Time to Maximum concentration
Time to Maximum concentration of AUR106
Time frame: Day 1 and Day 15
Pharmacokinetics: Terminal elimination half life
Terminal elimination half life of AUR106
Time frame: Day 1 and Day 15
Adverse Events
Adverse Events as characterized by type, frequency, severity (as per CTCAE Version 5.0), timing, seriousness, and relationship to study therapy.
Time frame: Through study completion, an average of 1 year
Laboratory abnormalities
Number of participants with abnormal laboratory tests results
Time frame: Through study completion, an average of 1 year
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