NSCLC (Advanced Non-small Cell Lung Cancer)Phase 1NCT07085091
A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors
A Phase 1 study testing ALX2004 in people with NSCLC (Advanced Non-small Cell Lung Cancer) and HNSCC, run by ALX Oncology Inc. at 12 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer), HNSCC, CRC (Colorectal Cancer)
- What is being tested?
- ALX2004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 12 sitesUnited States
- Study dates
- 18 Aug 2025to Dec 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 11 recruiting
- Recruiting
ALX Center 10
Columbus, Ohio, 43210
- Recruiting
ALX Center 2
Fairfax, Virginia, 22031
- Recruiting
ALX Center 8
Farmington Hills, Michigan, 48334
- Recruiting
ALX Center 3
Grand Rapids, Michigan, 49546
- Recruiting
ALX Center 5
Houston, Texas, 77030
- Recruiting
ALX Center 9
La Jolla, California, 92037
- Recruiting
ALX Center 12
Morristown, New Jersey, 07962
- Recruiting
ALX Center 6
Portland, Oregon, 97213
- Recruiting
ALX Center 11
Santa Monica, California, 90404
- Withdrawn
ALX Center 1
Spokane, Washington, 99208
- Recruiting
ALX Center 7
Tampa, Florida, 33612
- Recruiting
ALX Center 4
West Valley City, Utah, 84119
About this study
Official 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
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
Read the 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.
- Conditions
- NSCLC (Advanced Non-small Cell Lung Cancer), HNSCC, CRC (Colorectal Cancer), ESCC, Colo-rectal Cancer, Head and Neck Cancer
- Being tested
- ALX2004
- Keywords
- ALX2004, EGFR, Solid Tumors, metastatic, Antibody Drug Conjugate, ADC, HNSCC, CRC, Lung, Non small cell lung cancer, esophageal, EGFR ADC
- Medical subject headings
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALX2004Drug
ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV Infusion
ALX2004Drug
ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion
ALX2004Drug
ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion
| Study group | Role | What they receive |
|---|---|---|
| ALX2004 Phase 1a (Dose Escalation) | Experimental | ALX2004 will be administered. Patients will be enrolled into escalating dose levels during the dose escalation phase Receives: 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 Receives: 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 Receives: Drug: ALX2004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: Up to 2 years from first patient dosed in dose expansion phase
Secondary outcomes (13)
Phase 1a and 1b: Maximum Concentration (Cmax)
To evaluate the Cmax of ALX2004
Measured: Up to 2 years
Phase 1a and 1b: Time of Maximum Plasma Concentration (Tmax)
To evaluate the Tmax of ALX2004
Measured: Up to 2 years
Phase 1a and 1b: Clearance (CL)
To evaluate the clearance of ALX2004
Measured: Up to 2 years
Phase 1a and 1b: Area under the concentration time curve (AUC)
To evaluate the AUC of ALX2004
Measured: Up to 2 years
Phase 1a and 1b: Terminal elimination half-life (t1/2)
To evaluate the t1/2 of ALX2004
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start18 Aug 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ALX Oncology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085091
- Sponsor's protocol ID
- ALX2004-01
- Status last verified
- May 2026
- First submitted
- 27 Jun 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No