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Also known as AN4005-dose level 0
AN4005 · 1 trial · 2 indications
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 |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
AN4005 is an investigational small molecule being studied for the treatment of advanced solid tumors and advanced lymphoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AN4005 is being developed by Adlai Nortye Ltd., whose American Depositary Shares trade under the ticker ANL. The company is conducting a first-in-human dose escalation study of the drug.
AN4005 is in Phase 1 clinical development. It is currently being evaluated in a first-in-human dose escalation study that is recruiting participants. The drug is investigational and has not been approved for any use.
AN4005 is being studied in a Phase 1 clinical trial with the identifier NCT04999384. This first-in-human dose escalation study is recruiting 31 participants with advanced solid tumors or advanced lymphoma at sites in the United States and China.
Yes, AN4005 is also known as AN4005-dose level 0. This alternative name refers to the initial dose level being evaluated in the Phase 1 clinical trial of the drug.