ALX2004 for Cancer

Recruiting at 3 trial locations

Overseen By Alan Sandler, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ALX Oncology Inc.

Must not be taking: ADCs with TOP1

Disqualifiers: Local therapy candidates, Life expectancy <3 months, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ALX2004 for individuals with certain advanced or metastatic solid tumors, such as some forms of head and neck, lung, esophageal, and colorectal cancers. The primary goal is to assess the safety of ALX2004 and determine the optimal dose. Participants should have tumors that are not treatable with surgery and must have already tried other cancer treatments without success. This trial may suit those with persistent tumors who have exhausted standard therapy options. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that ALX2004 is likely to be safe for humans?

Research shows that ALX2004 is a unique drug that combines a cancer-fighting medicine with an antibody. This combination targets cancer cells while minimizing damage to healthy skin cells. Studies indicate that it has a lower risk of causing skin problems, which are common with similar treatments. Although current studies have not yet provided safety data, ALX2004 has been approved for its first human trials, indicating successful performance in earlier lab and animal tests. These tests ensure the treatment is safe enough for human use. As this is an early trial, the primary focus is on safety, and researchers will closely monitor participants for any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard cancer treatments, which often include chemotherapy and radiation, ALX2004 is unique because it targets cancer cells with a novel mechanism of action. Researchers are excited about ALX2004 because it aims to selectively attack tumor cells while sparing healthy ones, potentially reducing side effects compared to traditional therapies. Additionally, its flexible dosing phases, including dose escalation and dose expansion, allow for tailored treatment approaches that could improve effectiveness and safety for patients.

What evidence suggests that ALX2004 might be an effective treatment for cancer?

Research shows that ALX2004 holds promise in fighting certain cancers. Early lab studies found it can shrink or halt tumor growth. These studies also suggest that ALX2004 is likely safe for patients. This treatment targets a protein called EGFR, which often aids tumor growth. Although more information from human trials is needed, early results are encouraging for treating solid tumors. Participants in this trial will receive ALX2004 in different phases, including dose escalation, dose exploration, and dose expansion, to further evaluate its safety and effectiveness. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic cancers including colorectal, non-small cell lung, squamous cell carcinoma of the head and neck, and esophageal cancer. Participants must have tumors that express a protein called EGFR. Specific health conditions may exclude some individuals.

Inclusion Criteria

My bone marrow functions properly.

My kidney and liver are functioning well.

I am physically active and can care for myself.

Exclusion Criteria

My condition can be treated with the goal of curing it.

My doctor expects me to live more than 3 months and my cancer is not quickly getting worse.

I have not been treated with ADCs that contain TOP1 inhibitors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a Dose Escalation

Participants are enrolled into escalating dose levels to determine the recommended dose for expansion

Up to 28 days

Phase 1a Dose Exploration

Participants are enrolled into 1 or 2 dose levels for further exploration of safety and efficacy

Up to 2 years

Phase 1b Dose Expansion

Participants receive the recommended phase 2 dose to further evaluate safety and efficacy

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ALX2004

Trial Overview The study tests ALX2004, an experimental drug designed to target cancer cells by recognizing EGFR. It's a first-in-human study meaning it's the first time this drug is being tested in people to see if it's safe and how well it works.

How Is the Trial Designed?

Group I: ALX2004 Phase 1b (Dose Expansion) Experimental Treatment 1 Intervention

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

Group II: ALX2004 Phase 1a (Dose Exploration) Experimental Treatment 1 Intervention

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

Group III: ALX2004 Phase 1a (Dose Escalation) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

ALX Oncology Inc.

Lead Sponsor

Trials

9

Recruited

1,200+

Citations

1. ir.alxoncology.com ir.alxoncology.com/news-releases/news-release-details/alx-oncology-announces-preclinical-data-and-phase-1-trial

ALX Oncology Announces Preclinical Data and Phase 1 ... "Our preclinical findings have shown potent anti-tumor activity and a favorable toxicity profile supporting our advancement of ALX2004 into the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07085091

NCT07085091 | A First in Human Study of ALX2004 With ... This study consists of Phase 1a Dose finding, comprising of Dose Escalation portion followed by Dose Exploration, and a Phase 1b Dose Expansion.

3. firstwordpharma.com firstwordpharma.com/story/6518916

ALX Oncology Reports Third Quarter 2025 Financial ... Given the promising preclinical findings we have seen to date for ALX2004 which demonstrate a favorable toxicity profile and potent anti-tumor ...

4. targetedonc.com targetedonc.com/view/fda-advances-alx2004-to-phase-1-trials-in-egfr-solid-tumors

FDA Advances ALX2004 to Phase 1 Trials in EGFR+ Solid ... The FDA has granted clearance to the IND application of ALX2004, a potential best- and first-in-class ADC for the treatment of EGFR-expressing solid tumors.

5. finance.yahoo.com finance.yahoo.com/news/alx-oncology-announces-preclinical-data-163000231.html

ALX Oncology Announces Preclinical Data and Phase 1 ... ALX2004-01 is a first-in-human study to evaluate the safety, tolerability, and preliminary efficacy of ALX2004 in patients with advanced or ...

6. ir.alxoncology.com ir.alxoncology.com/news-releases/news-release-details/alx-oncology-doses-first-patient-phase-1-dose-escalation-trial

Release Details In addition, ALX2004 has shown dose-dependent activity across a range of tumors, EGFR expression levels and mutations. Potent activity in tumor ...