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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06755450 | Study Evaluating Safety Pharmacokinetics and Pharmacodynamics of AUR112 in Patients With Relapsed Advanced Lymphoma | PHASE1 | RECRUITING | 40 | — | — | Jan 15, 2025 | Jan 15, 2028 | Jan 13, 2026 | 19 | India |
Number of participants with dose limiting toxicities (DLT) taking AUR112
The assessment of safety was based on the frequency of deaths, adverse event (AE), serious adverse event (SAE)s leading to discontinuation of study drug, and abnormalities in specific laboratory assessments. AEs and laboratory values will be graded for severity according to NCI CTCAE version 5.0
Determine selected dose(s) to be studied in future clinical trials
Maximum concentration of AUR112
Tmax in hours
Area under the curve (AUC) of AUR 112 in h\* mcg/mL
Average time the drugs stays in the body
Terminal elimination half-life of AUR 112 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 |
|---|---|---|
| AUR112 | EXPERIMENTAL | Experimental: AUR112, 100mg to 1200mg Currently, six (6) planned dose levels are 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, and 1200 mg once daily (QD). AUR112: Once daily |
| Name | Type | Description |
|---|---|---|
| AUR112 | 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 ≥ 1000/μL (without WBC growth factor support) 2. Platelet count: For patie...