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

Launched by ALX ONCOLOGY INC. · Jul 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called ALX2004, designed to treat certain advanced or spreading solid tumors, including types of lung, head and neck, colorectal, and esophageal cancers. ALX2004 is a special kind of treatment called an antibody-drug conjugate, which works by targeting a specific protein (EGFR) found on cancer cells to deliver medicine directly to them. This is an early-phase study (Phase 1), meaning it’s the first time this drug is being tested in people to understand how safe it is and what dose might work best.

People who might be eligible for this trial are adults with advanced or metastatic cancers that can’t be removed by surgery and who have already received some standard treatments. The trial includes patients with specific types of lung, head and neck, colorectal, or esophageal cancer who meet certain health requirements, like good kidney, liver, and bone marrow function. Participants should not have very rapidly worsening disease or be expected to live less than three months. If accepted, participants will receive ALX2004 and be closely monitored for side effects and response to the treatment. This study is currently recruiting patients and is open to both men and women between 18 and 74 years old. It’s important to know that this trial is testing a new treatment, so the main goal is to evaluate safety and find the right dose before further studies can determine how well it works.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants with locally advanced, recurrent or metastatic disease; locally advanced or recurrent disease must not be amenable to resection with curative intent
• * Participants with the following histologically confirmed tumor types for:
• 1. Dose Escalation:
• • HNSCC - Received no more than 3 prior lines of therapy in the advanced or metastatic setting NSCLC - For participants with a targetable molecular alteration: received appropriate standard targeted therapy and no more than 2 prior lines of systemic chemotherapy in the advanced/metastatic setting
• • For patients without a targetable molecular alteration: received platinum-based chemotherapy and CPI (in combination or separately), and have received no more than 2 prior lines of systemic chemotherapy in the advanced/metastatic setting
• • ESCC - Received no more than 3 prior lines of therapy in the advanced/metastatic setting CRC (left-sided) - For participants with a targetable molecular alteration (including dMMR or MSI-H): Received appropriate standard therapy for the alteration, at least 2 prior lines of systemic chemotherapy, and no more than 4 prior lines of therapy in the advanced/metastatic setting For participants without a targetable molecule alteration: Received at least 2 prior lines of systemic chemotherapy (including an oxaliplatin-based chemotherapy), vascular endothelial growth factor (VEGF)-based therapy, and no more than 4 prior lines of therapy in the advanced/metastatic setting.
• • 2. Dose Exploration: All or a subset of tumors tested in Dose Escalation
• • 3. Dose Expansion: Subset of tumors tested in Dose Escalation
• • Adequate Bone Marrow Function
• • Adequate Renal \& Liver Function
• • Adequate Performance Status
• Exclusion Criteria:
• • Participants with disease suitable for local therapy with curative intent.
• • Has a life expectancy of less than 3 months and/or has rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator
• • Prior treatment with any ADCs that have an active TOP1 inhibitor-based component