New 'Smart Bomb' drug targets Hard-to-Treat cancers in first human trial
NCT ID NCT07085091
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study is testing a new drug called ALX2004 in people with advanced lung, head and neck, esophageal, or colorectal cancers that have not responded to standard treatments. ALX2004 is an antibody-drug conjugate designed to deliver a cancer-killing payload directly to cells that have a protein called EGFR on their surface. The trial will first find a safe dose and then check for signs that the drug can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ALX2004 (an antibody-drug conjugate that targets EGFR on cancer cells)
- What this could lead to
- If this works, it could point toward a new treatment option for people with advanced lung, head and neck, esophageal, or colorectal cancers that have stopped responding to other therapies.
- What could go wrong
- This is a very early (Phase 1) trial, so the main goal is safety, not effectiveness. The drug may not shrink tumors, and side effects could be significant. Only a small number of people will receive the potentially effective dose.
Why investors are watching
ALX Oncology is testing ALX2004, an antibody drug conjugate that targets EGFR, in people with advanced or metastatic solid tumors. This is a first-in-human phase 1 trial with 170 planned participants, and for a micro-cap company, the safety and early disease-control results from this readout will largely determine whether the drug has a future. A clear signal of tumor shrinkage or stable disease could validate the company's main pipeline asset, while a weak result would leave ALX with few other options.
If it works: If ALX2004 shows acceptable safety and signs of disease control in this early trial, the company could advance the drug to later-stage testing and attract partnership interest. A positive readout would give ALX a credible path forward in a competitive field.
If it fails: Phase 1 trials fail often, and a poor safety profile or lack of tumor response could halt development of ALX2004. For a company this small, a failure or major delay would likely leave it without a lead program and force it to reassess its entire strategy.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 170 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants with locally advanced, recurrent or metastatic histologically confirmed HNSCC, NSCLC, ESCC, CRC; locally advanced or recurrent disease must not be amenable to resection with curative intent 1. Dose Escalation: Participants who have relapsed or progressed following prior anticancer therapy in the advanced/metastatic setting and for whom no approved or standard therapy is available. 2. Dose Exploration and Dose Expansion: The following tumor-specific criteria also apply. These cohorts will include all or a subset of these tumors. 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 participants 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 - 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. * 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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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ALX Center 1
RECRUITINGSpokane, Washington, 99208, United States
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ALX Center 2
RECRUITINGFairfax, Virginia, 22031, United States
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ALX Center 3
RECRUITINGGrand Rapids, Michigan, 49546, United States
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ALX Center 4
RECRUITINGWest Valley City, Utah, 84119, United States
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ALX Center 5
RECRUITINGHouston, Texas, 77030, United States
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ALX Center 6
RECRUITINGPortland, Oregon, 97213, United States
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ALX Center 7
RECRUITINGTampa, Florida, 33612, United States
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ALX Center 8
RECRUITINGFarmington Hills, Michigan, 48334, United States
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