ALX Oncology Doses First Patient in Phase 1 Trial for ALX2004 ADC.

ALX Oncology has dosed the first patient in a Phase 1 clinical trial for ALX2004, a potential best- and first-in-class antibody-drug conjugate for EGFR-expressing solid tumors. The trial aims to evaluate the safety and efficacy of ALX2004, which has shown positive preclinical data with dose-dependent anti-tumor activity and a favorable safety profile. Initial safety data is expected in the first half of 2026.

ALX Oncology (NASDAQ: ALXO) has taken a significant step forward in its mission to develop novel cancer therapies by dosing the first patient in a Phase 1 clinical trial for ALX2004, a potential best- and first-in-class antibody-drug conjugate (ADC) targeting EGFR-expressing solid tumors. The trial, designated as NCT07085091, is an open-label, multicenter study evaluating ALX2004's safety and efficacy in patients with advanced or metastatic tumors, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), and colorectal cancer (CRC).

ALX2004 is designed to address the toxicity limitations that have hampered earlier EGFR-targeted ADCs. It features an affinity-tuned EGFR antibody and a proprietary topoisomerase I inhibitor payload, engineered to maximize the therapeutic window and reduce toxicity. Preclinical data has shown superior stability, dose-dependent activity, and a favorable safety profile without significant EGFR-related skin toxicity [1].

The Phase 1 trial follows a standard oncology development path, beginning with dose escalation in previously treated patients with advanced or metastatic NSCLC, HNSCC, ESCC, and CRC. The trial will then proceed to dose exploration and expansion portions. Initial safety data is expected in the first half of 2026.

ALX Oncology's Chief Executive Officer, Jason Lettmann, commented on the milestone, stating, "Dosing of the first patient in the Phase 1 trial is an important milestone in ALX Oncology’s mission to develop a pipeline of best-in-class drugs. ALX2004 is our first ADC and treating our first patient with this drug is a significant step forward in fulfilling the potential of EGFR-targeted ADCs. Our preclinical data supports our conviction that ALX2004, with its optimized antibody, linker, and payload, has the potential to overcome the toxicity challenges that have limited earlier generation EGFR-targeted ADCs. We look forward to enrolling this trial and expect to report initial safety data in the first half of 2026" [2].

ALX2004's unique design, which includes an affinity-tuned antibody with a binding epitope distinct from approved EGFR antibodies and a proprietary topoisomerase I inhibitor payload, sets it apart from previous EGFR-targeted ADCs. The drug's robust preclinical data, demonstrating dose-dependent activity and a favorable safety profile across various tumor types and EGFR expression levels, supports its potential as a differentiated therapy in the EGFR-ADC class [1].

While the trial is in its early stages, and initial human safety data won't be available until the first half of 2026, ALX Oncology's progress with ALX2004 represents a promising development in the field of EGFR-targeted therapies. As with all early-stage oncology assets, the true clinical profile of ALX2004 will only become clear once human data accumulates.

References:
[1] https://www.stocktitan.net/news/ALXO/alx-oncology-doses-first-patient-in-phase-1-dose-escalation-trial-qo4atyg54gzz.html
[2] https://www.stocktitan.net/news/ALXO/alx-oncology-doses-first-patient-in-phase-1-dose-escalation-trial-qo4atyg54gzz.html