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 the treatment of advanced non-small cell lung cancer (NSCLC). It is also being studied in other advanced or metastatic solid tumors, including head and neck squamous cell carcinoma, colorectal cancer, and esophageal squamous cell carcinoma.
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 the drug in patients with advanced or metastatic selected solid tumors.
ALX2004 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is a first-in-human study designed to evaluate the safety and tolerability of ALX2004 in patients with advanced solid tumors.
ALX2004 is being studied in a Phase 1 clinical trial registered as NCT07085091. This is a first-in-human study enrolling approximately 170 patients with advanced or metastatic solid tumors, including NSCLC, head and neck cancer, colorectal cancer, and esophageal squamous cell carcinoma. The trial is currently recruiting participants in the United States.
ALX2004 is a small molecule therapeutic being investigated for the treatment of advanced solid tumors. The specific molecular target of ALX2004 has not been disclosed in the available clinical trial information. The ongoing Phase 1 study is evaluating the drug in a biomarker-unselected patient population.