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NCT07085091 · ClinicalTrials.gov registry record · Phase 1
A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors
A Phase 1 study of Colorectal Cancer and Head and Neck Cancer, sponsored by ALX Oncology.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 170
- Enrollment target
- 7
- Study locations
NCT07085091: Recruiting Phase 1 study of Colorectal Cancer and Head and Neck Cancer, sponsored by ALX Oncology.
NCT07085091 is a Phase 1 study of Colorectal Cancer and Head and Neck Cancer that is actively recruiting participants, run by ALX Oncology. The registered enrollment target is 170 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (89% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07085091, a Phase 1 study of Colorectal Cancer and Head and Neck Cancer, is actively recruiting participants, sponsored by ALX Oncology.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 170 participants
- Enrollment target
- 7
- Study locations
Study 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
Primary Outcome
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
Conditions Studied
Interventions
- DRUG ALX2004
Study Locations (7)
Florida
- ALX Center 7 - Tampa
Michigan
- ALX Center 3 - Grand Rapids
Oregon
- ALX Center 6 - Portland
Texas
- ALX Center 5 - Houston
Utah
- ALX Center 4 - West Valley City
Virginia
- ALX Center 2 - Fairfax
Washington
- ALX Center 1 - Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2025-08-18 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT07085091 shows while recruiting
NCT07085091 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (89% lower).
The record links to 7 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which ALX2004 is the first listed.
NCT07085091 lists 7 locations in 7 states (Florida, Michigan, Oregon).
Frequently Asked Questions
What is clinical trial NCT07085091 about?
NCT07085091 is a clinical study titled "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
What is the current status of trial NCT07085091?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 170 participants. The study started on 2025-08-18. Estimated completion is 2027-12.
What conditions does trial NCT07085091 study?
This clinical trial studies the following conditions: Colorectal Cancer, Head and Neck Cancer, HNSCC, CRC, Colorectal Cancer, Esophageal Squamous Cell Carcinoma (ESCC).
What interventions are being tested in trial NCT07085091?
The interventions under investigation include: ALX2004 (DRUG).
Who is sponsoring clinical trial NCT07085091?
This trial is sponsored by ALX Oncology, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07085091 being conducted?
This trial has 7 study locations across Florida, Michigan, Oregon, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07085091's enrollment target sits among peer trials
170 163rd of 381 higher than 219 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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