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Also known as AN9025 oral capsule
AN9025 · 1 trial · 2 indications
• Incidence, nature, and severity of adverse events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
| Arm | Type | Description |
|---|---|---|
| AN9025 Treatment | EXPERIMENTAL | Oral administration of AN9025 capsules |
| Name | Type | Description |
|---|---|---|
| AN9025 oral capsule | DRUG | AN9025 is a novel, oral, small molecule pan-RAS (ON) inhibitor that binds cyclophilin A (CypA) with a slow dissociation rate, forming a tri-complex with guanosine triphosphate (GTP) bound state of both mutant and wild-type RAS proteins. AN9025 exhibits potent anti-proliferative activity in RAS-addicted cancer cell lines, demonstrates favorable pharmacokinetics (PK), pharmacodynamics and an acceptable tolerability profile in vivo. |
Inclusion Criteria: 1. Aged ≥18 years old at the time of informed consent. 2. Able to provide informed consent voluntarily before any study-related activities and according to local guidelines. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 4. Have an estimated life expe...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
AN9025 is an investigational oral small molecule developed by Adlai Nortye Ltd. American Depositary Shares (ticker ANL). It is being studied in adults with advanced or metastatic solid tumors that harbor RAS mutations. AN9025 is a biomarker-selected therapy, meaning trial enrollment is limited to patients whose tumors carry RAS mutations.
AN9025 is being evaluated for the treatment of advanced or metastatic solid tumors harboring RAS mutations. It is not approved for any indication and remains in clinical development. The Phase 1 study enrolls adults 18 years and older with RAS-mutated solid tumors at sites in the United States.
AN9025 targets RAS, a protein class of signaling molecules that are frequently mutated in cancer. By inhibiting RAS, AN9025 is designed to act on tumors driven by RAS mutations. The Phase 1 trial specifically selects participants whose tumors harbor RAS mutations, making RAS mutation status the key enrollment biomarker.
AN9025 is being developed by Adlai Nortye Ltd. American Depositary Shares, which trades under the ticker ANL. The company is running the Phase 1 program for the oral capsule in advanced or metastatic RAS-mutated solid tumors.
AN9025 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The single active trial is a Phase 1 study with an estimated enrollment of 118 participants, and no completed trials of AN9025 have been reported.
AN9025 is being studied in one recruiting Phase 1 trial, NCT07252479, titled Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations. The study has an estimated enrollment of 118 participants, is uncontrolled, is not randomized or double blinded, and enrolls adults of all sexes in the United States.
Yes. AN9025 oral capsule is another name for AN9025, the investigational RAS-targeted small molecule from Adlai Nortye Ltd. American Depositary Shares (ticker ANL). Both names refer to the same Phase 1 asset being studied in advanced or metastatic solid tumors harboring RAS mutations.