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

NCT07085091 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ALX2004-01
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 7

Brief 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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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)

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

Secondary Outcomes (13)

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

  Up to 2 years

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

  Up to 2 years

• Phase 1a and 1b: Clearance (CL)

  Up to 2 years

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

  Up to 2 years

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

  Up to 2 years

Study Arms (3)

ALX2004 Phase 1a (Dose Escalation)

EXPERIMENTAL

ALX2004 will be administered. Patients will be enrolled into escalating dose levels during the dose escalation phase

Drug: ALX2004

ALX2004 Phase 1a (Dose Exploration)

EXPERIMENTAL

ALX2004 will be administered. All or a subset of tumors tested in dose escalation will enroll into 1 or 2 dose levels during the dose exploration phase

Drug: ALX2004

ALX2004 Phase 1b (Dose Expansion)

EXPERIMENTAL

ALX2004 will be administered. Patients will receive the recommended phase 2 dose during the dose expansion phase

Drug: ALX2004

Interventions

ALX2004 DRUG

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

ALX2004 Phase 1a (Dose Escalation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ALX Oncology Inc.: lead

Study Sites (7)

ALX Center 7

Tampa, Florida, 33612, United States

RECRUITING

ALX Center 3

Grand Rapids, Michigan, 49546, United States

RECRUITING

ALX Center 6

Portland, Oregon, 97213, United States

RECRUITING

ALX Center 5

Houston, Texas, 77030, United States

RECRUITING

ALX Center 4

West Valley City, Utah, 84119, United States

RECRUITING

ALX Center 2

Fairfax, Virginia, 22031, United States

RECRUITING

ALX Center 1

Spokane, Washington, 99208, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Colorectal Neoplasms; Colonic Neoplasms; Head and Neck Neoplasms; Esophageal Squamous Cell Carcinoma; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Esophageal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Athanasios Tsiatis, MD

CONTACT

650-466-7125; info@alxoncology.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The dose escalation and dose exploration portions of the study will be non-randomized. For each tumor type selected for dose expansion, either one or two dose(s) and schedule(s) may be tested. If two doses/schedules are tested, allocation will be randomized.

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 25, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)