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.
This is a Phase I, Open Label, Dose-Escalation, First-in-Human study in adult patients with select relapsed advanced malignancies. The safety and tolerability of oral AUR107 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 the safety, pharmacokinetics/pharmacodynamics, and determine the Optimal Biological Dose of AUR107 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
50
Once daily
First cycle Dose Limiting Toxicities (DLT)
Assess dose limiliting toxicities of AUR107
Time frame: 28 days
Safety of AUR107 as measured by the number of participants with treatment-related adverse events (AE) graded according to NCI CTCAE version 5.0
The assessment of safety was based on the frequency of deaths, AEs, SAEs, AEs leading to discontinuation of study drug, and abnormalities in specific clinical laboratory assessments. AEs and laboratory values will be graded for severity according to the NCI CTCAE version 5.0.
Time frame: 28 days
Optimal Biological Dose
Determine optimal Biological dose
Time frame: 28 days
Pharmacokinetics: Maximum concentration (Cmax)
Maximum concentration of AUR107
Time frame: Day 1 and Day 15
Pharmacokinetics: Time to Maximum concentration (Tmax)
Tmax in hours
Time frame: Day 1 and Day 15
Pharmacokinetics: Area under the curve (AUC)
Area under the curve (AUC) of AUR 107 in h\* mcg/mL
Time frame: Day 1 and Day 15
Pharmacokinetics: Mean Residence Time (MRT)
Average time the drugs stays in the body
Time frame: Day 1 and Day 15
Pharmacokinetics: Terminal elimination half-life
Terminal elimination half-life of AUR 107 in hours
Time frame: Day 1 and Day 15
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
HCG City Cancer Centre
Vijayawada, Andhra Pradesh, India
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Visakhapatnam, Andhra Pradesh, India
RECRUITINGPost-Graduate Institute of Medical Education and Research(PGIMER)
Chandigarh, Chandigarh, India
RECRUITINGApollo Hospital International Limited
Ahmedabad, Gujarat, India
RECRUITINGUniversal Superspeciality Hospital
Surat, Gujarat, India
RECRUITINGUnique Hospital Multispeciality and Research Institute
Surat, Gujarat, India
RECRUITINGKiran Hospital Multi Super Speciality Hospital & Research Centre
Surat, Gujarat, India
RECRUITINGPt.B.D Sharma PGIMS Rohtak
Rohtak, Haryana, India
RECRUITINGSri Shankara Cancer Hospital and Research Centre
Bangalore, Karnataka, India
ACTIVE_NOT_RECRUITINGHealthcare Global Enterprises Ltd
Bangalore, Karnataka, India
RECRUITING...and 27 more locations
Maximum concentration (Cmax) administered under fasting/fed condition
Compare in fast and fed conditions
Time frame: Day 8 and Day 9
Time to Maximum concentration (Tmax) administered under fasting/fed condition
Compare Tmax in fast and fed conditions
Time frame: Day 8 and Day 9
Area under curve (AUC) administered under fasting/fed condition
Compare AUC in fast and fed conditions
Time frame: Day 8 and Day 9