Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AN2025 · 1 trial · 1 indication
Number of participants with Dose Limiting Toxicities (DLTs)
The safety profile will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
| Arm | Type | Description |
|---|---|---|
| DLT Observation Period I - AN2025 and Atezolizumab | EXPERIMENTAL | During the DLT Observation I, patients will be treated with AN2025 and Atezolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent. The starting dose of AN2025 is 50 mg. If tolerated, then a subsequent cohort will escalate to 100 mg. A dose de-escalation cohort to 80 mg may occur if the 100 mg is not well tolerated. The dose of Atezolizumab will remain constant at 1200 mg every 3 weeks (Q3W) for each dose level of AN2025 and in each cohort. Atezolizumab is administered intravenously over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. |
| DLT Observation Period II - AN0025 and Atezolizumab | EXPERIMENTAL | During the DLT Observation II, patients will be treated with AN0025 and Atezolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent. The starting dose of AN0025 is 250 mg. If tolerated, then a subsequent cohort will escalate to 500 mg. If 250 mg AN0025 is not tolerated, de-escalate to 125 mg. The dose of Atezolizumab will remain constant at 1200 mg Q3W for each dose level of AN0025 and in each cohort. Atezolizumab is administered intravenously over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. |
| DLT Observation Period III - AN2025, AN0025 and Atezolizumab | EXPERIMENTAL | The DLT Observation III will be started after safety data review by the investigators and the sponsor of the double combination treatments in Observations I and II. Patients enrolled in Observation III will start with the recommended dose of AN0025 from Observation II, 1200 mg Atezolizumab, and AN2025 will start from 50 mg QD. Patients will be treated with all three study drugs until the patient experiences disease progression, unacceptable toxicity or withdraws consent. The dose of Atezolizumab will be the same (i.e., 1200 mg Q3W) regardless of dose levels of AN2025 and cohorts. Atezolizumab is administered intravenously over 60 minutes every three weeks. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. The dose of AN0025 as determined in Observation II will remain constant for each dose level of AN2025 and each cohort, unless the investigators and the sponsor determine that the toxicity comes from the AN0025 + Atezolizumab combination. |
| Name | Type | Description |
|---|---|---|
| AN2025 | DRUG | oral administration |
| AN0025 | DRUG | oral administration |
| Atezolizumab 1200 mg in 20 ML Injection | DRUG | infusion |
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 ≥3 months. 5. D...
AN2025 is an investigational small molecule being studied for the treatment of locally advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated in combination with other agents in patients with advanced solid tumors.
AN2025 is being developed by Adlai Nortye Ltd., a biopharmaceutical company listed on the stock exchange under the ticker symbol ANL. The company is conducting clinical trials to evaluate the safety and efficacy of AN2025 in patients with advanced solid tumors.
AN2025 is currently in Phase 1 clinical development. A Phase 1 trial has been completed, which enrolled 47 patients with locally advanced solid tumors. The drug remains investigational and is not yet approved for any indication.
AN2025 has been studied in a Phase 1 clinical trial registered as NCT04975958, titled "Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors." This trial was conducted in the United States and enrolled 47 adult patients with locally advanced solid tumors.
AN2025 is a small molecule therapeutic agent. Its specific molecular target has not been disclosed in available information. The drug is being evaluated in combination with other anticancer agents to treat advanced solid tumors, but its precise mechanism of action is not publicly detailed.