RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-07
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07085091

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants with locally advanced, recurrent or metastatic disease; locally advanced or recurrent disease must not be amenable to resection with curative intent
  2. * Participants with the following histologically confirmed tumor types for:
  3. 1. Dose Escalation:
  4. 2. Dose Exploration: All or a subset of tumors tested in Dose Escalation
  5. 3. Dose Expansion: Subset of tumors tested in Dose Escalation
  6. * Adequate Bone Marrow Function
  7. * Adequate Renal \& Liver Function
  8. * Adequate Performance Status
  1. * Participants with disease suitable for local therapy with curative intent.
  2. * 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
  3. * Prior treatment with any ADCs that have an active TOP1 inhibitor-based component

Contacts and Locations

Study Contact

Vinny Hayreh, MD
CONTACT
650-466-7125
info@alxoncology.com
Alan Sandler, MD
CONTACT
650-466-7125
info@alxoncology.com

Study Locations (Sites)

NEXT Oncology
Fairfax, Virginia, 22031
United States
Summit Cancer Center
Spokane, Washington, 99208
United States

Collaborators and Investigators

Sponsor: ALX Oncology Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-07
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • ALX2004
  • EGFR
  • Solid Tumors
  • metastatic
  • Antibody Drug Conjugate
  • ADC
  • HNSCC
  • CRC
  • Lung
  • Non small cell lung cancer
  • esophageal
  • EGFR ADC

Additional Relevant MeSH Terms

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