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RecruitingInterventionalPhase 1

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

NCT ID: NCT07085091Sponsor: ALX Oncology Inc.Last updated: 2026-05-12

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

Detailed description

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.

Arms & interventions

  • DrugALX2004

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

  • DrugALX2004

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

  • DrugALX2004

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

Outcome measures

Primary

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

    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

    Time frame: Up to 28 days

  • Phase 1a: Incidence of treatment emergent adverse events

    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

    Time frame: Up to 2 years from first dose

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

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

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

Secondary

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

    Time frame: Up to 2 years

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

    Time frame: Up to 2 years

  • Phase 1a and 1b: Clearance (CL)

    Time frame: Up to 2 years

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

    Time frame: Up to 2 years

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

    Time frame: Up to 2 years

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

    Time frame: Up to 2 years from first dose

  • 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

  • Phase 1b: Incidence of treatment emergent adverse events

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

  • 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

  • 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

  • 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

  • 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

  • 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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (8)

ALX Center 7

Tampa, Florida, 33612

Recruiting

ALX Center 8

Farmington Hills, Michigan, 48334

Recruiting

ALX Center 3

Grand Rapids, Michigan, 49546

Recruiting

ALX Center 6

Portland, Oregon, 97213

Recruiting

ALX Center 5

Houston, Texas, 77030

Recruiting

ALX Center 4

West Valley City, Utah, 84119

Recruiting

ALX Center 2

Fairfax, Virginia, 22031

Recruiting

ALX Center 1

Spokane, Washington, 99208

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