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NCT Number: NCT07085091

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

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Key information

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer) Bronchial Neoplasms CRC (Colorectal Cancer) Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms ESCC Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Esophageal Squamous Cell Carcinoma (ESCC) Gastrointestinal Diseases Gastrointestinal Neoplasms HNSCC Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ALX Center 7, Tampa, Florida, United States

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About this study

This study consists of Phase 1a Dose finding, comprising of Dose Escalation portion followed by Dose Exploration, and a Phase 1b Dose Expansion. The study will enroll previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC). Up to 170 patients are expected to be enrolled in the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.
  • 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

Treatment and study plan

ALX2004

Drug

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

Primary outcomes

  1. Phase 1a: Incidence of dose limiting toxicities (DLTs)

    Time frame: 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

  2. Phase 1a: Incidence of treatment emergent adverse events

    Time frame: 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

  3. Phase 1b: Overall Response Rate (ORR) per investigator assessment using RECIST v1.1

    Time frame: 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)

Secondary outcomes

  1. Phase 1a and 1b: Maximum Concentration (Cmax)

    Time frame: Up to 2 years

    To evaluate the Cmax of ALX2004

  2. Phase 1a and 1b: Time of Maximum Plasma Concentration (Tmax)

    Time frame: Up to 2 years

    To evaluate the Tmax of ALX2004

  3. Phase 1a and 1b: Clearance (CL)

    Time frame: Up to 2 years

    To evaluate the clearance of ALX2004

  4. Phase 1a and 1b: Area under the concentration time curve (AUC)

    Time frame: Up to 2 years

    To evaluate the AUC of ALX2004

  5. Phase 1a and 1b: Terminal elimination half-life (t1/2)

    Time frame: Up to 2 years

    To evaluate the t1/2 of ALX2004

  6. Phase 1a: Overall Response Rate (ORR) per investigator assessment using RECIST v1.1

    Time frame: Up to 2 years from first dose

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

  7. Phase 1a and 1b: Evaluate the immunogenicity of ALX2004

    Time frame: Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase

    Measured by the presence of human plasma ADA (Anti-ALX2004 antibodies)

  8. Phase 1b: Incidence of treatment emergent adverse events

    Time frame: Up to 2 years from first patient dosed in dose expansion phase

    AEs as characterized by type, frequency, severity (as graded by the NCI CTCAE v.5.0) timing, seriousness, and relationship to study drug. Laboratory abnormalities as characterized by type, frequency, severity and timing

  9. Phase 1a and 1b: Progression Free Survival (PFS)

    Time frame: Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase

    PFS is defined as the time (in months) from the date of the first dose of ALX2004 to the date of the first instance of progressive disease or death

  10. Phase 1a and 1b: Overall Survival (OS)

    Time frame: Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase

    OS is defined as the time (in months) from the date of the first dose of ALX2004 to the date of death

  11. Phase 1a and 1b: Best Overall Response (BOR)

    Time frame: Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase

    BOR is defined as the best response reached during the course of the trial from the response categories of CR, PR, SD, PD, and No Response using RECIST v1.1

  12. Phase 1a and 1b: DCR (Disease Control Rate)

    Time frame: Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase

    DCR is defined as the proportion of participants whose BOR is PR, CR, or SD

  13. Phase 1a and 1b: Duration of Response (DoR)

    Time frame: Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase

    DoR is defined as the time (in months) from the first instance of a BOR, of CR/PR until the date of the first instance of progressive disease

Study contacts

Contact information is provided by the study sponsor or research team.

Athanasios Tsiatis, MD

CONTACT

[email protected]

650-466-7125

Sponsors and collaborators

Lead sponsor

ALX Oncology Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 25, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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