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ALX2004 for Advanced or Metastatic Solid Tumors

This study is testing a new drug called ALX2004 for people with advanced or metastatic (spread to other parts of the body) non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), or colorectal cancer (CRC). ALX2004 is a targeted therapy, meaning it focuses on specific features of cancer cells, in this case, EGFR. The main goals are to see how safe ALX2004 is and if it can shrink tumors. You may be able to join if your cancer has progressed after previous treatments and you are at least 18 years old. Up to 170 people are expected to join this study.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know you are receiving ALX2004. It will enroll up to 170 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for side effects for up to 2 years from your first dose. Tumor responses will be assessed for up to 2 years from the first patient dosed in the expansion phase.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07085091

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
ALX Oncology Inc.
~170 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:ALX2004

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Incidence of dose limiting toxicities (DLTs)
Measured over Up to 28 days
+2 more outcomes measured

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)
HNSCC
CRC (Colorectal Cancer)
ESCC
Colo-rectal Cancer
Head and Neck Cancer
Esophageal Squamous Cell Carcinoma (ESCC)

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NCT07085091

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • ALX Center 1

    Spokane, Washingtonno site contact published

    Recruiting

  • ALX Center 2

    Fairfax, Virginiano site contact published

    Recruiting

  • ALX Center 3

    Grand Rapids, Michiganno site contact published

    Recruiting

  • ALX Center 4

    West Valley City, Utahno site contact published

    Recruiting

  • ALX Center 5

    Houston, Texasno site contact published

    Recruiting

  • ALX Center 6

    Portland, Oregonno site contact published

    Recruiting

  • ALX Center 7

    Tampa, Floridano site contact published

    Recruiting

  • ALX Center 8

    Farmington Hills, Michiganno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Athanasios Tsiatis, MD
[email protected]
650-466-7125
Email the study team

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Eligibility criteria

Inclusion

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
Adequate Bone Marrow Function
Adequate Renal \& Liver Function
Adequate Performance Status

Exclusion

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

What this trial measures

  • Phase 1a: Incidence of dose limiting toxicities (DLTs)Up to 28 days

    Phase 1a: Number and proportion of participants enrolled in the dose escalation phase who experience dose-limiting toxicities (DLTs), received at least one dose of ALX2004 and completed the DLT evaluation

  • Phase 1a: Incidence of treatment emergent adverse eventsUp to 2 years from first dose

    Phase 1a: Adverse Events as characterized by type, frequency, severity (NCI CTCAE v5.0), timing, seriousness, and relationship to the study drug in order to establish the RDE. Laboratory abnormalities as characterized by type, frequency, severity and timing

  • Phase 1b: Overall Response Rate (ORR) per investigator assessment using RECIST v1.1Up to 2 years from first patient dosed in dose expansion phase

    Phase 1b: ORR is defined as proportion of participants whose BOR is complete response (CR) or partial response (PR)