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
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Among 3,366 studies in Carcinoma, Non-Small-Cell Lung with a site in United States — 518 open to participants now, 892 under way, 142 of them phase 3. Carcinoma, Non-Small-Cell Lung · United States.
Among the 3,366 studies in Carcinoma, Non-Small-Cell Lung with a site in United States, this one is the 714th largest by planned enrollment of the 2,993 interventional ones that give a count, is one of 149 that started in 2025, is one of 926 in phase 1, reaches primary completion later than 401 of the 890 other live ones, and was the 3,189th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →518 of the 3,366 studies in Carcinoma, Non-Small-Cell Lung with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Sites in United States
Ages 18+
Indiana University · Sites in United States
Ages 18+
Exelixis · Sites in United States
Ages 18+
University of Chicago · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
3,366 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1,409 · Phase 2 1,590 · Phase 3 382 · Phase 4 13
First in 1990; this study’s year is marked. 149 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 170 is above the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 56 across the 2,993 interventional studies, 100 across the 246 observational. Of the 2,297 that completed or were terminated, 1,053 (46%) have results posted.
This tab as a report to print or save as PDF → With an account.
1,735 of 3,366 have an industry lead sponsor. The 10 most frequent:
ALX Oncology Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
ALX Oncology Inc. has 1 study filed under Carcinoma, Non-Small-Cell Lung — fewer than ten, so there is no comparison to draw.
270 of the studies in Carcinoma, Non-Small-Cell Lung with a site in United States that are under way reach primary completion within a year, 25 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05987956Phase 3Medicine Invention Design, IncPharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms | 2026-11-18 |
| NCT03815643Phase 3EMD Serono Research & Development Institute, Inc.Avelumab Program Rollover Study | 2026-11-24 |
| NCT04585490Phase 3Stanford UniversityAdaptive ctDNA-Based Personalization of Treatment During Consolidation Therapy in NSCLC | 2026-12 |
| NCT03637816Phase 3M.D. Anderson Cancer CenterAnamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer | 2026-12-31 |
| NCT05221840Phase 3AstraZenecaA Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer | 2027-01-08 |
Add all 270 to your calendar (.ics) → With an account.
Among the 3,366 studies in Carcinoma, Non-Small-Cell Lung with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with locally advanced, recurrent or 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 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Jun 2027, 22 months after the start.
Of 473 industry-sponsored phase 1 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 66. This study's planned 22 months is below that.
Counting every sponsor, half of 699 studies reached it within 50 months; a quarter within 31 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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.
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Carcinoma, Non-Small-Cell Lung →
ALX Oncology Inc.