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Recruiting Phase 1

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

NCT07085091 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2025-08-18
Last updated
2026-09-30

Condition(s) studied

NSCLC (Advanced Non-small Cell Lung Cancer)HNSCCCRC (Colorectal Cancer)ESCCColo-rectal CancerHead and Neck CancerEsophageal Squamous Cell Carcinoma (ESCC)

Investigational drug(s) / intervention(s)

ALX2004ALX2004ALX2004

ALX2004: ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV Infusion

ALX2004: ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion

ALX2004: ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 events — Up 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 v1.1 — Up 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)

Trial sites (12)

FacilityCityRegionStatus
ALX Center 9 La Jolla California Recruiting
ALX Center 11 Santa Monica California Recruiting
ALX Center 7 Tampa Florida Recruiting
ALX Center 8 Farmington Hills Michigan Recruiting
ALX Center 3 Grand Rapids Michigan Recruiting
ALX Center 12 Morristown New Jersey Recruiting
ALX Center 10 Columbus Ohio Recruiting
ALX Center 6 Portland Oregon Recruiting
ALX Center 5 Houston Texas Recruiting
ALX Center 4 West Valley City Utah Recruiting
ALX Center 2 Fairfax Virginia Recruiting
ALX Center 1 Spokane Washington Withdrawn
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07085091 on ClinicalTrials.gov ↗ ← All trials in the USA