deltatrials
Recruiting INTERVENTIONAL NCT07085091

A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors

A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants With Advanced or Metastatic Select Solid Tumors

Sponsor: ALX Oncology Inc.

Conditions CRC (Colorectal Cancer) Colo-rectal Cancer ESCC Esophageal Squamous Cell Carcinoma (ESCC) HNSCC Head and Neck Cancer NSCLC (Advanced Non-small Cell Lung Cancer)
Interventions ALX2004 ALX2004 ALX2004
Updated 6 times since 2025 Last updated: Apr 20, 2026 Started: Aug 18, 2025 Primary completion: Jun 1, 2027 Completion: Dec 1, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates CRC (Colorectal Cancer) and Colo-rectal Cancer and is currently actively recruiting participants. ALX Oncology Inc. leads this study, which shows 6 recorded versions since 2025 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

This study consists of Phase 1a Dose finding, comprising of Dose Escalation portion followed by Dose Exploration, and a Phase 1b Dose Expansion. The study will enroll 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). Up to 170 patients are expected to be enrolled in the study.

This study consists of Phase 1a Dose finding, comprising of Dose Escalation portion followed by Dose Exploration, and a Phase 1b Dose Expansion. The study will enroll 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). Up to 170 patients are expected to be enrolled in the study.

Status Flow

~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshotRecruiting~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshotRecruiting~Oct 2025 – ~Nov 2025 · 31 days · monthly snapshotRecruiting~Nov 2025 – ~Feb 2026 · 3 months · monthly snapshotRecruiting~Feb 2026 – ~Apr 2026 · 3 months · monthly snapshotRecruitingApr 23, 2026 – present · 3 months · daily APIRecruiting

Change History

6 versions recorded

  1. Apr 23, 2026 — Present [daily]

    Recruiting

    Phase: PHASE1 → None

  2. Feb 2026 — Apr 2026 [monthly]

    Recruiting PHASE1

  3. Nov 2025 — Feb 2026 [monthly]

    Recruiting PHASE1

  4. Oct 2025 — Nov 2025 [monthly]

    Recruiting PHASE1

  5. Sep 2025 — Oct 2025 [monthly]

    Recruiting PHASE1

▶ Show 1 earlier version

  1. Aug 2025 — Sep 2025 [monthly]

    Recruiting PHASE1

    First recorded

Eligibility Summary

A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors

Contact Information

Sponsor contact:
  • ALX Oncology Inc.
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations