Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AUR107 · 1 trial · 1 indication
Assess dose limiliting toxicities of AUR107
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.
Determine optimal Biological dose
Maximum concentration of AUR107
Tmax in hours
Area under the curve (AUC) of AUR 107 in h\* mcg/mL
Average time the drugs stays in the body
Terminal elimination half-life of AUR 107 in hours
Compare in fast and fed conditions
Compare Tmax in fast and fed conditions
Compare AUC in fast and fed conditions
| Arm | Type | Description |
|---|---|---|
| AUR107, 5mg to 200mg | EXPERIMENTAL | Currently, planned dose levels are 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD, 90 mg QD, 135 mg QD, and 200 mg QD |
| Name | Type | Description |
|---|---|---|
| AUR107 | DRUG | Once daily |
Inclusion Criteria: 1. Males and females ≥ 18 years of age. 2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1. 3. Acceptable bone marrow and organ function at screening as described below: 1. ANC ≥ 1500/μL (without WBC growth factor support) 2. Platelet count ≥ 100,00...
AUR107 is an investigational small molecule being studied for the treatment of relapsed malignant solid neoplasms. It is currently in Phase 1 clinical development, with an ongoing trial evaluating its safety and efficacy in patients with relapsed advanced malignancies.
AUR107 is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY. The company is conducting a Phase 1 clinical trial of AUR107 in patients with relapsed advanced malignancies.
AUR107 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 1 trial, known as SHAKTI-1, is currently recruiting participants to evaluate the safety and efficacy of AUR107.
AUR107 is being studied in a single Phase 1 clinical trial with the identifier NCT05865002, titled 'A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)'. This trial is recruiting 50 participants in India.
The Phase 1 clinical trial of AUR107, NCT05865002, is an uncontrolled, open-label study. It is not randomized and not double-blinded. The trial is designed to evaluate the safety and efficacy of AUR107 as a single agent in patients with relapsed advanced malignancies.