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, meaning it has not yet been approved by regulatory authorities and its safety and efficacy are still being evaluated in clinical trials.
AUR107 targets CREBBP/EP300, which are proteins involved in gene regulation and are implicated in cancer. By targeting these proteins, AUR107 is designed to interfere with cancer cell growth, though its exact mechanism of action is still under investigation in clinical trials.
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 clinical trials to evaluate the drug's safety and efficacy in patients with relapsed advanced malignancies.
AUR107 is currently in Phase 1 clinical development. It is an investigational drug, meaning it is not yet approved for commercial use. The ongoing Phase 1 trial is designed to assess its safety, tolerability, and preliminary efficacy in patients with relapsed malignant solid neoplasms.
AUR107 is being evaluated in a 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 participants in India and aims to enroll approximately 50 patients aged 18 years and older.
No, AUR107 is the drug being studied, while SHAKTI-1 is the name of the clinical trial evaluating it. The trial, identified as NCT05865002, is a Phase 1 study assessing the safety and efficacy of AUR107 in patients with relapsed advanced malignancies.