Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05865002 | A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1) | PHASE1 | RECRUITING | 50 | — | — | Sep 5, 2023 | Jun 1, 2027 | Apr 17, 2026 | 37 | India |
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...