A Phase 1 interventional study of ALX2004 and ALX2004 in NSCLC (Advanced Non-small Cell Lung Cancer), HNSCC and CRC (Colorectal Cancer), sponsored by ALX Oncology Inc.. Recruiting at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by ALX Oncology Inc. · Phase 1, Interventional, and Treatment
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
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.
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
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.
Exclusion Criteria:
ALX2004 will be administered. Patients will be enrolled into escalating dose levels during the dose escalation phase
Drug: ALX2004
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 will be administered. Patients will receive the recommended phase 2 dose during the dose expansion phase
Drug: ALX2004
ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV Infusion
ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion
ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion
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
Phase 1a and 1b: Maximum Concentration (Cmax)
To evaluate the Cmax of ALX2004
Time frame: Up to 2 years
Phase 1a and 1b: Time of Maximum Plasma Concentration (Tmax)
To evaluate the Tmax of ALX2004
Time frame: Up to 2 years
Phase 1a and 1b: Clearance (CL)
To evaluate the clearance of ALX2004
Time frame: Up to 2 years
Phase 1a and 1b: Area under the concentration time curve (AUC)
To evaluate the AUC of ALX2004
Time frame: Up to 2 years
Phase 1a and 1b: Terminal elimination half-life (t1/2)
To evaluate the t1/2 of ALX2004
Time frame: Up to 2 years
Phase 1a: Overall Response Rate (ORR) per investigator assessment using RECIST v1.1
Phase 1a: 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 dose
Phase 1a and 1b: Evaluate the immunogenicity of ALX2004
Measured by the presence of human plasma ADA (Anti-ALX2004 antibodies)
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
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
Time frame: Up to 2 years from first patient dosed in dose expansion phase
Phase 1a and 1b: Progression Free Survival (PFS)
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
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)
OS is defined as the time (in months) from the date of the first dose of ALX2004 to the date of death
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)
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
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)
DCR is defined as the proportion of participants whose BOR is PR, CR, or SD
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)
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
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
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carcinoma, Non-Small-Cell Lung→
ALX Oncology Inc.