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Also known as AN4005-dose level 0, AN4005-food effect
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, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| 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 in Phase 1 clinical development and is not yet approved for any indication. Adlai Nortye Ltd. is evaluating the drug in patients with advanced disease.
AN4005 targets PD-L1. PD-L1 is a checkpoint protein that tumors use to suppress immune responses. By binding to PD-L1, AN4005 is designed to block this interaction and restore the immune system's ability to recognize and attack cancer cells. It is a small molecule, not an antibody.
AN4005 is being developed by Adlai Nortye Ltd., whose American Depositary Shares trade under the ticker ANL. The company is running a first-in-human Phase 1 study of the drug in the United States and China.
AN4005 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is a first-in-human dose escalation study in patients with advanced solid tumors and advanced lymphoma.
AN4005 is being evaluated in one active clinical trial, NCT04999384, titled First in Human, Dose Escalation Study of AN4005. The trial is currently recruiting and has an estimated enrollment of 31 participants. It is being conducted in the United States and China.
AN4005-dose level 0 and AN4005-food effect are alternative names or sub-study labels associated with AN4005. They refer to the same investigational drug candidate. AN4005 is the primary name used for the small molecule PD-L1 inhibitor being developed by Adlai Nortye Ltd.