ALX Oncology Commences Phase 1 Trial for ALX2004, a Novel ADC for EGFR-Expressing Tumors

ALX Oncology has commenced a Phase 1 trial for ALX2004, a novel ADC targeting EGFR-expressing tumors. The trial aims to evaluate ALX2004's safety and efficacy in treating solid tumors such as NSCLC, HNSCC, ESCC, and CRC. Preclinical data has shown ALX2004's superior stability, anti-tumor activity, and favorable safety profile. Initial safety data is expected in the first half of 2026.

ALX Oncology (NASDAQ: ALXO) has initiated a Phase 1 clinical trial for ALX2004, a novel antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR)-expressing solid tumors. The trial, identified as NCT07085091, aims to evaluate ALX2004's safety and efficacy in patients with advanced or metastatic 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 limitations of existing EGFR-targeted ADCs, particularly the toxicity issues that have historically narrowed the therapeutic window. The drug features an optimized design with an affinity-tuned EGFR antibody and a proprietary topoisomerase I inhibitor payload. Preclinical data has shown ALX2004's superior stability, dose-dependent anti-tumor activity, and a favorable safety profile without significant EGFR-related skin toxicity [1].

The Phase 1 trial follows a standard oncology development path, starting with a dose escalation portion to determine the optimal dosage. This will be followed by dose exploration and a Phase 1b dose expansion. The study will enroll patients with previously treated advanced or metastatic tumors of the specified types.

Initial safety data for ALX2004 is expected in the first half of 2026. While preclinical results are promising, investors should be aware that the true clinical profile will only become clear as human data accumulates.

ALX Oncology's CEO, Jason Lettmann, stated, "Dosing of the first patient in the Phase 1 trial is an important milestone in our 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 has the potential to overcome the toxicity challenges that have limited earlier generation EGFR-targeted ADCs."

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