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Also known as Intravenous AN4035, Intravenous AN4035 followed by intravenous EGFR Inhibitor., AN4035 followed by EGFR Inhibitor
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 by Adlai Nortye for advanced solid tumors. It is designed to bind CEACAM5 and is being studied in patients whose tumors carry RAS mutations and show high CEACAM5 expression. AN4035 is in Phase 1 clinical development and is not approved for any use.
AN4035 targets CEACAM5, a cell surface protein, and is classified as an antibody-drug conjugate. The Phase 1 study enrolls patients selected for high CEACAM5 expression, so the CEACAM5 biomarker is used to identify appropriate participants alongside RAS mutation status.
AN4035 is being developed by Adlai Nortye Ltd., which trades on the Nasdaq under the ticker ANL as American Depositary Shares. The company is the sponsor of the Phase 1 study of AN4035 in advanced cancers with RAS mutations and high CEACAM5 expression.
AN4035 is in Phase 1 clinical development. Its single trial, NCT07686445, is a Phase 1 study that is currently recruiting participants. AN4035 is investigational and has not been approved by the FDA or any other regulator for the treatment of solid tumors or any other condition.
AN4035 is being studied in one Phase 1 trial, NCT07686445, titled A Study of AN4035 in Advanced Cancers With RAS Mutations and High CEACAM5 Expression. The trial is recruiting up to 228 participants aged 18 years and older of all sexes, and it is being conducted in Australia.
Yes. AN4035 is also referred to as intravenous AN4035, and some listings describe it as intravenous AN4035 followed by an intravenous EGFR inhibitor, or AN4035 followed by an EGFR inhibitor. These names refer to the same investigational agent, AN4035, being developed by Adlai Nortye.