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Also known as Intravenous AN4035
AN4035 · 1 trial · 3 indications
Incidence, nature, and severity of adverse events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Determination of the MTD for AN4035 by understanding the nature and frequency of dose limiting toxicity.
| Arm | Type | Description |
|---|---|---|
| Monotherapy AN4035 Treatment | EXPERIMENTAL | Part 1 dose escalation and back-fill cohorts of varying doses of AN4035 intravenously dosed and Part 2 MTD for expansion cohorts. |
| Combination AN4035 + EGFR Inhibitor Treatment | EXPERIMENTAL | Part 1: Dose escalation and back-fill cohorts of varying doses of AN4035 intravenously dosed followed by intravenous administration of an EGFR Inhibitor. Part 2 MTD dosing for AN4035 followed by intravenous administration of an EGFR Inhibitor. |
| Name | Type | Description |
|---|---|---|
| Intravenous AN4035 | DRUG | AN4035 is a CAN4035 is a CEACAM5-targeting ADC designed to selectively deliver a proprietary pan-RAS(ON) inhibitor payload to tumor cells. |
| Intravenous AN4035 followed by intravenous EGFR Inhibitor. | DRUG | AN4035 is a CAN4035 is a CEACAM5-targeting ADC designed to selectively deliver a proprietary pan-RAS(ON) inhibitor payload to tumor cells. EGFR inhibition and RAS signaling is mechanistically complementary, as EGFR functions upstream of RAS activation and may enhance pathway suppression and overcome therapeutic resistance. |
Inclusion Criteria: * 18 years old at the time of informed consent. Able to provide informed consent voluntarily before any trial-related activities and according to local guidelines. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Have histological or cytological evidenc...
AN4035 is an investigational small molecule antibody-drug conjugate being developed for the treatment of solid tumors, specifically in advanced cancers with RAS mutations and high CEACAM5 expression. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AN4035 targets CEACAM5, a cell surface protein that is overexpressed in certain solid tumors. As an antibody-drug conjugate, it is designed to deliver a cytotoxic agent to CEACAM5-expressing cancer cells. The drug is being studied in patients with RAS mutations and high CEACAM5 expression.
AN4035 is being developed by Adlai Nortye Ltd., a biopharmaceutical company listed on the American Depositary Shares under the ticker ANL. The company is conducting a Phase 1 clinical trial of AN4035 in Australia for advanced cancers with RAS mutations and high CEACAM5 expression.
AN4035 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is designed to evaluate the safety and tolerability of AN4035 in patients with advanced solid tumors.
AN4035 is being studied in a Phase 1 clinical trial with the identifier NCT07686445. This trial is titled 'A Study of AN4035 in Advanced Cancers With RAS Mutations and High CEACAM5 Expression' and is planned to enroll 228 participants in Australia. The trial is not yet recruiting and is open to adults aged 18 and older.
Yes, AN4035 is also known as Intravenous AN4035. The drug is administered intravenously and is being investigated for the treatment of solid tumors with RAS mutations and high CEACAM5 expression. The alternative name reflects the route of administration used in clinical trials.