ALX Oncology Doses First Patient in Phase 1 Dose Escalation Trial Evaluating ADC ALX2004 for the Treatment of EGFR-Expressing Solid Tumors
ALX Oncology (NASDAQ:ALXO) has initiated its Phase 1 clinical trial of ALX2004, a potential first-in-class antibody-drug conjugate (ADC) targeting EGFR-expressing solid tumors. The first patient has been dosed in the open-label multicenter study (NCT07085091).
The trial will evaluate ALX2004 in patients with advanced or metastatic solid tumors, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), and colorectal cancer (CRC). The study comprises Phase 1a dose escalation, dose exploration, and Phase 1b dose expansion portions.
ALX2004 features an optimized design with an affinity-tuned EGFR antibody and proprietary topoisomerase I inhibitor payload. Preclinical data has shown superior stability, dose-dependent activity, and a favorable safety profile without significant EGFR-related skin toxicity. Initial safety data is expected in the first half of 2026.
ALX Oncology (NASDAQ:ALXO) ha avviato lo studio clinico di Fase 1 di ALX2004, un potenziale anticorpo coniugato (ADC) di prima classe che mira ai tumori solidi che esprimono EGFR. Il primo paziente è stato trattato nello studio multicentrico in aperto (NCT07085091).
Lo studio valuterà ALX2004 in pazienti con tumori solidi avanzati o metastatici, inclusi carcinoma polmonare non a piccole cellule (NSCLC), carcinoma squamoso della testa e del collo (HNSCC), carcinoma esofageo squamoso (ESCC) e carcinoma colorettale (CRC). Lo studio comprende una fase 1a di escalation di dose, una fase di esplorazione delle dosi e una fase 1b di espansione della dose.
ALX2004 presenta un design ottimizzato con un anticorpo anti‑EGFR a affinità modulata e un payload inibitore della topo I proprietario. I dati preclinici hanno mostrato maggiore stabilità, attività dipendente dalla dose e un profilo di sicurezza favorevole senza significativa tossicità cutanea correlata a EGFR. I primi dati sulla sicurezza sono attesi nella prima metà del 2026.
ALX Oncology (NASDAQ:ALXO) ha iniciado su ensayo clínico de Fase 1 de ALX2004, un posible anticuerpo‑fármaco conjugado (ADC) de primera clase dirigido a tumores sólidos que expresan EGFR. El primer paciente ha recibido la dosis en el estudio multicéntrico abierto (NCT07085091).
El ensayo evaluará ALX2004 en pacientes con tumores sólidos avanzados o metastásicos, incluidos cáncer de pulmón no microcítico (NSCLC), carcinoma escamoso de cabeza y cuello (HNSCC), carcinoma escamoso de esófago (ESCC) y cáncer colorrectal (CRC). El estudio comprende la parte de escalada de dosis de Fase 1a, exploración de dosis y la expansión de dosis de Fase 1b.
ALX2004 presenta un diseño optimizado con un anticuerpo anti‑EGFR con afinidad ajustada y un payload inhibidor de la topoisomerasa I propietario. Los datos preclínicos han mostrado mayor estabilidad, actividad dependiente de la dosis y un perfil de seguridad favorable sin toxicidad cutánea significativa relacionada con EGFR. Se esperan los primeros datos de seguridad en la primera mitad de 2026.
ALX Oncology (NASDAQ:ALXO)는 EGFR을 발현하는 고형종양을 표적하는 최초의 계열 가능성이 있는 항체‑약물 접합체(ADC) ALX2004의 1상 임상시험을 시작했으며, 개방형 다기관 연구에서 첫 환자에게 투여를 완료했습니다 (NCT07085091).
본 임상은 진행성 또는 전이성 고형종양 환자, 특히 비소세포폐암(NSCLC), 두경부 편평세포암(HNSCC), 식도 편평세포암(ESCC), 대장암(CRC) 등을 대상으로 ALX2004를 평가합니다. 연구는 1상a 용량상승, 용량탐색 및 1상b 용량확대 단계로 구성됩니다.
ALX2004는 친화도 조정된 EGFR 항체와 독점적 탑이소머라제 I 억제제 페이로드를 결합한 최적화된 설계를 갖추고 있습니다. 전임상 데이터에서 우수한 안정성, 용량 의존적 활성 및 EGFR 관련 피부독성이 크게 없는 우호적 안전성 프로파일이 관찰되었습니다. 초기 안전성 데이터는 2026년 상반기에 공개될 예정.
ALX Oncology (NASDAQ:ALXO) a lancé son essai clinique de phase 1 pour ALX2004, un conjugué anticorps‑médicament (ADC) potentiellement de première classe ciblant les tumeurs solides exprimant l’EGFR. Le premier patient a été traité dans l’étude multicentrique en ouvert (NCT07085091).
L’essai évaluera ALX2004 chez des patients atteints de tumeurs solides avancées ou métastatiques, notamment cancer du poumon non à petites cellules (NSCLC), carcinome épidermoïde tête et cou (HNSCC), carcinome épidermoïde de l’œsophage (ESCC) et cancer colorectal (CRC). L’étude comprend une phase 1a d’escalade de dose, une phase d’exploration des doses et une phase 1b d’expansion des doses.
ALX2004 présente une conception optimisée avec un anticorps anti‑EGFR à affinité ajustée et un payload inhibiteur de la topoisomérase I propriétaire. Les données précliniques ont montré une stabilité supérieure, une activité dépendante de la dose et un profil de sécurité favorable sans toxicité cutanée significative liée à l’EGFR. Les premières données de sécurité sont attendues au premier semestre 2026.
ALX Oncology (NASDAQ:ALXO) hat die Phase‑1‑Studie zu ALX2004 initiiert, einem potenziellen First‑in‑Class Antikörper‑Wirkstoff‑Konjugat (ADC) für EGFR‑expressierende solide Tumoren. Der erste Patient wurde in der offenen multizentrischen Studie dosiert (NCT07085091).
Die Studie wird ALX2004 bei Patienten mit fortgeschrittenen oder metastasierten soliden Tumoren prüfen, einschließlich nicht‑kleinzelligem Lungenkarzinom (NSCLC), Plattenepithelkarzinom von Kopf und Hals (HNSCC), Plattenepithelkarzinom der Speiseröhre (ESCC) und kolorektalem Karzinom (CRC). Sie umfasst eine Phase‑1a Dosiseskalation, eine Dosisexplorationsphase und eine Phase‑1b Dosis‑Expansionsphase.
ALX2004 verfügt über ein optimiertes Design mit einem affinitäts‑feinabgestimmten EGFR‑Antikörper und einem proprietären Topoisomerase‑I‑Inhibitor‑Payload. Präklinische Daten zeigten überlegene Stabilität, dosisabhängige Wirksamkeit und ein günstiges Sicherheitsprofil ohne relevante EGFR‑bedingte Hauttoxizität. Erste Sicherheitsdaten werden in der ersten Hälfte 2026 erwartet.
- Potential first-in-class EGFR ADC with optimized components for maximum therapeutic window
- Preclinical data shows superior stability compared to other ADCs in its class
- Demonstrated dose-dependent anti-tumor activity across various tumor types
- No EGFR-related skin toxicity or payload-related lung disease observed in preclinical studies
- Initial safety data won't be available until first half 2026
- Early Phase 1 stage with no human efficacy data yet
- Faces competition in crowded EGFR-targeting therapeutic space
Insights
ALX Oncology begins Phase 1 trial of ALX2004, a novel EGFR-targeted ADC with potential advantages over competitors.
ALX Oncology has initiated the Phase 1 clinical trial for ALX2004, dosing its first patient in a significant development milestone. ALX2004 represents the company's first antibody-drug conjugate (ADC) targeting EGFR-expressing solid tumors, positioned as a potential best- and first-in-class therapy. The drug incorporates several engineered optimizations - including an affinity-tuned antibody with a novel binding epitope, a proprietary topoisomerase I inhibitor payload, and enhanced linker stability.
The Phase 1 trial (NCT07085091) follows a standard oncology development path with dose escalation followed by expansion cohorts. The study targets patients with advanced or metastatic tumors including non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and colorectal cancer - all cancers where EGFR expression plays a significant role.
What sets ALX2004 apart from previous EGFR-targeted ADCs is its focus on addressing the toxicity limitations that have hampered earlier compounds. Preclinical data suggests ALX2004 maintains efficacy across various tumor types and EGFR expression levels while potentially avoiding common EGFR inhibitor toxicities like skin reactions and interstitial lung disease that have historically narrowed therapeutic windows for this class.
While preclinical results appear promising, investors should note that initial human safety data won't be available until the first half of 2026, indicating a relatively long development timeline before efficacy signals might emerge. As with all early-stage oncology assets, the true clinical profile will only become clear once human data accumulates.
- A potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors, ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window
-First-in-human trial of ALX2004 builds upon body of positive preclinical data demonstrating dose dependent anti-tumor activity and favorable safety profile
-Initial safety data anticipated in first half 2026
SOUTH SAN FRANCISCO, Calif., Aug. 19, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or the"Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced that the first patient has been dosed in the Company’s Phase 1 clinical trial for ALX2004, a potential best- and first-in-class, epidermal growth factor receptor (EGFR) ADC that is being studied for the treatment of EGFR-expressing solid tumors.
"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,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. "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."
The Phase 1 clinical trial (NCT07085091) is a first-in-human, open-label multicenter study evaluating ALX2004 in participants with advanced or metastatic select EGFR-expressing solid tumors. The study consists of a Phase 1a dose escalation portion followed by dose exploration, and a Phase 1b dose expansion. The dose escalation portion of the trial will enroll patients with previously treated 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). All or a subset of these tumor types may be included in the dose exploration and expansion portions of the trial.
ALX2004: Optimized for Success Based on Rigorous Drug Design Process
Developed by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is a uniquely designed EGFR-targeted ADC where every component is optimized to maximize the therapeutic window by reducing toxicity. This includes an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies. ALX2004 also has a proprietary Top1i payload engineered to offer enhanced bystander effect with improved linker stability for on-target delivery of payload.
Robust Preclinical Data: Supporting Differentiation in EGFR-ADC Class
Preclinical data supports ALX2004’s differentiated linker-payload construct, which has demonstrated superior stability versus other ADCs in its class, with dose-dependent activity and a favorable safety profile. In addition, ALX2004 has shown dose-dependent activity across a range of tumors, EGFR expression levels and mutations. Potent activity in tumor models supports its potential for treating patients with EGFR-expressing tumors. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, supportive of a potentially differentiated safety profile.
About ALX Oncology
ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and entered the clinic in a Phase 1 trial in August 2025. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (SEC), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Relations Contact:
Elhan Webb, CFA, IR Consultant
ewebb@alxoncology.com
Media Contact:
Audra Friis, Sam Brown Healthcare Communications
audrafriis@sambrown.com
(917) 519-9577
FAQ
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