Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALX2004 · 1 trial · 7 indications
Phase 1a: Number and proportion of participants enrolled in the dose escalation phase who experience dose-limiting toxicities (DLTs), received at least one dose of ALX2004 and completed the DLT evaluation
Phase 1a: Adverse Events as characterized by type, frequency, severity (NCI CTCAE v5.0), timing, seriousness, and relationship to the study drug in order to establish the RDE. Laboratory abnormalities as characterized by type, frequency, severity and timing
Phase 1b: ORR is defined as proportion of participants whose BOR is complete response (CR) or partial response (PR)
| Arm | Type | Description |
|---|---|---|
| ALX2004 Phase 1a (Dose Escalation) | EXPERIMENTAL | ALX2004 will be administered. Patients will be enrolled into escalating dose levels during the dose escalation phase |
| ALX2004 Phase 1a (Dose Exploration) | EXPERIMENTAL | ALX2004 will be administered. All or a subset of tumors tested in dose escalation will enroll into 1 or 2 dose levels during the dose exploration phase |
| ALX2004 Phase 1b (Dose Expansion) | EXPERIMENTAL | ALX2004 will be administered. Patients will receive the recommended phase 2 dose during the dose expansion phase |
| Name | Type | Description |
|---|---|---|
| ALX2004 | DRUG | ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV Infusion |
Inclusion Criteria: * Participants with locally advanced, recurrent or metastatic histologically confirmed HNSCC, NSCLC, ESCC, CRC; locally advanced or recurrent disease must not be amenable to resection with curative intent 1. Dose Escalation: Participants who have relapsed or progressed follow...
ALX2004 is an investigational small molecule being developed for advanced non-small cell lung cancer (NSCLC). It is currently in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied in patients with advanced or metastatic selected solid tumors, including NSCLC.
ALX2004 targets EGFR, the epidermal growth factor receptor. By targeting EGFR, the drug is designed to interfere with signaling pathways that can drive tumor growth. This mechanism is being evaluated in a Phase 1 clinical trial for advanced solid tumors, including NSCLC.
ALX2004 is being developed by ALX Oncology Holdings Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALXO. The company is conducting a first-in-human study of ALX2004 in patients with advanced or metastatic selected solid tumors.
ALX2004 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 1 trial is recruiting participants in the United States to evaluate the drug's safety and tolerability in advanced solid tumors.
ALX2004 is being studied in a single Phase 1 clinical trial with the identifier NCT07085091. This first-in-human study is recruiting 170 participants with advanced or metastatic solid tumors, including NSCLC, head and neck cancer, colorectal cancer, and esophageal squamous cell carcinoma. The trial is being conducted in the United States.
ALX2004 is a distinct investigational small molecule targeting EGFR. While it shares a molecular target with other EGFR inhibitors, it is a separate drug candidate developed by ALX Oncology. No alternative names for ALX2004 have been disclosed in the clinical trial information.