Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BKM120
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 drug being developed by Adlai Nortye Ltd. for locally advanced solid tumors. It is a pan-PI3K inhibitor and has been studied in a Phase 1 clinical trial in the United States. AN2025 is not approved and remains in clinical development.
AN2025 is being studied for the treatment of locally advanced solid tumors, a broad oncology indication. Its only recorded clinical trial enrolled 47 adult patients with advanced solid tumors. Because the drug is still investigational, it is not approved for any use outside of clinical research.
AN2025 targets PI3K, specifically as a pan-PI3K inhibitor. This means it is designed to act on the phosphoinositide 3-kinase pathway, a signaling route commonly dysregulated in solid tumors. The drug is a small molecule and was studied in combination with AN0025 and atezolizumab.
AN2025 is being developed by Adlai Nortye Ltd., whose American Depositary Shares trade under the ticker ANL. The company sponsored the Phase 1 study of AN2025 in advanced solid tumors conducted in the United States.
AN2025 is in Phase 1 clinical development. Its single recorded trial, NCT04975958, was a Phase 1 study that has been completed. The drug is investigational and has not been approved by the FDA for any indication.
AN2025 has been evaluated in one clinical trial, NCT04975958, titled Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors. The Phase 1 study enrolled 47 patients with locally advanced solid tumors in the United States and is now completed, with no active trials currently listed.