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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04999384 | First in Human, Dose Escalation Study of AN4005 | PHASE1 | RECRUITING | 31 | — | — | Sep 27, 2021 | Dec 1, 2026 | Nov 18, 2025 | 7 | United States, China |
All AEs, SAEs and dose modifications will be collected
An event is considered to be a DLT if the event occurs within the first 28 days of treatment and meets the dose-limiting toxicity criteria, unless it can be clearly established that the event is unrelated to treatment
Blood and urine samples will be collected for analysis of lab parameters. Vital signs, physical examinations and organ-specific parameters will be collected at specified time points
| Arm | Type | Description |
|---|---|---|
| AN4005 dose level 0 | ACTIVE_COMPARATOR | One sentinel patient will be orally dosed at 50 mg AN4005 BID. If this dose for one cycle is deemed to be tolerable upon review of safety data and PK data, the dose of AN4005 will be escalated to next level: dose level 1. |
| AN4005 dose level 1 | ACTIVE_COMPARATOR | Three patients will be orally dosed at 100 mg AN4005 BID. Based on the number of DLT events during the first cycle, dosing decisions will be made, including add 3 patients at the same dose level (1 DLT), escalation to dose level 3 (\<1/6 DLT), de-escalate to lower dose or stop (\>1/6 DLT). |
| AN4005 dose level 2 | ACTIVE_COMPARATOR | Three patients will be orally dosed at 200 mg AN4005 BID. Based on the number of DLT events during the first cycle, dosing decisions will be made, including add 3 patients at the same dose level (1 DLT), escalation to dose level 3 (\<1/6 DLT), de-escalate to lower dose or stop (\>1/6 DLT). |
| AN4005 dose level 3 | ACTIVE_COMPARATOR | Three patients will be orally dosed at 400 mg AN4005 BID. Based on the number of DLT events during the first cycle, dosing decisions will be made, including add 3 patients at the same dose level (1 DLT), escalation to dose level 4 (\<1/6 DLT), de-escalate to lower dose or stop (\>1/6 DLT). |
| AN4005 dose level 4 | ACTIVE_COMPARATOR | Three patients will be orally dosed at 600 mg AN4005 BID. Based on the number of DLT events during the first cycle, dosing decisions will be made, including add 3 patients at the same dose level (1 DLT), de-escalate to lower dose or stop (\>1/6 DLT). |
| AN4005 food effect | ACTIVE_COMPARATOR | The effect of a high-fat meal on the PK of AN4005 will be evaluated in a separate cohort of approximately 6 patients after a safe and clinically relevant dose is identified during the dose finding part of the study. |
| Name | Type | Description |
|---|---|---|
| AN4005-dose level 0 | DRUG | 50mg BID |
| AN4005-dose level 1 | DRUG | 100mg BID |
| AN4005-dose level 2 | DRUG | 200mg BID |
| AN4005-dose level 3 | DRUG | 400mg BID |
| AN4005-dose level 4 | DRUG | 600mg BID |
| AN4005-food effect | DRUG | Dose to be determined upon the MTD determination |
Inclusion Criteria: * 1\. Age ≥ 18 years at the time of informed consent and have provided signed informed consent for the trial. 2\. Willing and able to comply with all aspects of the protocol. 3\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 4\. Life expectancy...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |