EOS006215 for Cancer

No longer recruiting at 8 trial locations

Overseen By iTeos Belgium SA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: iTeos Belgium SA

Must not be taking: Anticancer, Antibacterial, Antiviral, Antifungal

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and effectiveness of a new treatment called EOS006215 for individuals with advanced solid tumors, which are cancers that have spread and cannot be surgically removed. Researchers are testing EOS006215 both alone and in combination with other cancer treatments to evaluate its effectiveness in shrinking tumors. Suitable candidates for this trial have solid tumors unresponsive to standard treatments and must be able to perform daily activities independently. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop any prior systemic anticancer treatments at least 3 weeks before starting the study. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that EOS006215, a new cancer treatment, has just begun testing in people, so limited safety information is available. However, similar treatments are generally well-tolerated. Studies with these treatments indicate that most people experienced manageable side effects.

When combined with other cancer drugs, EOS006215 caused mild skin issues in some patients, which were easily treated with medication. As this is the first human trial of EOS006215, the primary goal is to assess its safety, making close monitoring of any side effects a crucial part of the study. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about EOS006215 because it offers a novel approach to cancer treatment by potentially altering the way the body interacts with cancer cells. Unlike current treatments that primarily focus on directly attacking cancer cells, EOS006215 works by enhancing the immune system's ability to recognize and fight cancer more effectively. The drug can be used alone or in combination with pembrolizumab, another immune-enhancing treatment, which could lead to better outcomes for patients. This unique mechanism of action makes EOS006215 a promising candidate in the fight against cancer.

What evidence suggests that EOS006215 might be an effective treatment for cancer?

Research has shown that EOS006215 targets a specific part of certain immune cells called TREM2, which is believed to help the immune system respond to tumors. By blocking TREM2, EOS006215 might enable the immune system to attack cancer cells more effectively. Early studies of similar treatments have shown promise in enhancing the immune system's ability to fight tumors. In this trial, some participants will receive EOS006215 as a monotherapy, while others will receive it in combination with other cancer-fighting drugs like pembrolizumab. This combination could potentially enhance the overall treatment's effectiveness. However, since EOS006215 is being tested in humans for the first time, more information is needed to confirm these effects in people. ^{1 3 4 6 7}

Who Is on the Research Team?

iTeos Belgium SA

Principal Investigator

iTeos Belgium SA

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors, including uterine tumors, who have not responded to standard treatments. Participants must be able to receive injections or infusions and have measurable disease as per certain criteria.

Inclusion Criteria

At least one tumor lesion measurable per RECIST v1.1

Have an estimated minimum life expectancy of ≥ 12 weeks

My advanced cancer has no standard treatment options left for me.

Exclusion Criteria

Pregnant or breastfeeding

I haven't had cancer treatment or experimental drugs in the last 3 weeks.

I haven't had major surgery in the last 5 weeks or minor surgery in the last 7 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Phase I dose escalation cohorts for EOS006215 as monotherapy and in combination with anticancer treatments

Up to 24 months

Dose Expansion

Phase Ib dose expansion cohort(s) to further evaluate the safety, tolerability, efficacy, PK and PD of EOS006215

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EOS006215

Trial Overview The study tests EOS006215, a new antibody targeting TREM2 on myeloid cells. It's given alone or with Pembrolizumab/other cancer drugs. The phases assess safety, dosage levels (Phase I), and its effect on tumor size (Phase Ib).

How Is the Trial Designed?

Group I: Part 1 Dose Escalation (Monotherapy) Experimental Treatment 1 Intervention

EOS006215 dose escalation as monotherapy

Group II: Part 1 Dose Escalation (Combination Therapy) Experimental Treatment 2 Interventions

EOS006215 dose escalation in combination with pembrolizumab or with other anticancer agents

Who Is Running the Clinical Trial?

iTeos Belgium SA

Lead Sponsor

Trials

9

Recruited

950+

Published Research Related to This Trial

In a study of 274 EGFR mutated non-small cell lung cancer patients with bone metastases, 28% experienced major skeletal related adverse events (SREs), with bone fractures being the most common (20%).

SREs were more likely to occur within the first 12 months of starting tyrosine kinase inhibitors (TKIs), highlighting the need for early intervention with bone resorption inhibitors to potentially reduce these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Prevalence and Early Occurrence of Skeletal Complications in EGFR Mutated NSCLC Patients With Bone Metastases. Laganà, M., Gurizzan, C., Roca, E., et al.[2022]

In a phase 2 trial involving 62 patients with KRASG12C-mutant colorectal cancer, sotorasib demonstrated a modest objective response rate of 9.7%, indicating some anti-tumor activity in patients who had previously undergone extensive treatment.

The safety profile of sotorasib was manageable, with 10% of patients experiencing grade 3 adverse events, primarily diarrhea, and no fatal events reported, suggesting it could be a viable option for heavily pretreated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sotorasib for previously treated colorectal cancers with KRASG12C mutation (CodeBreaK100): a prespecified analysis of a single-arm, phase 2 trial. Fakih, MG., Kopetz, S., Kuboki, Y., et al.[2022]

EGFR-targeting agents like C225 and ZD1839 show promise in treating cancers such as non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC), with C225 demonstrating synergy with chemotherapy and radiation in preclinical models.

Despite initial positive responses in phase I trials, large phase III studies of ZD1839 combined with chemotherapy did not show an increase in survival for advanced NSCLC patients, highlighting the need for further research into effective treatment combinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The epidermal growth factor receptor pathway and its inhibition as anticancer therapy. Janmaat, ML., Giaccone, G.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06877533

NCT06877533 | A First-in-Human Open-label, Phase I/Ib ... The study includes EOS006215 monotherapy and combination therapy with other anticancer agents in participants with advanced solid tumors. Detailed Description.

2. delta.larvol.com delta.larvol.com/Products/?ProductId=5b7fe9d9-bbd8-4cee-a997-b31bfde7887c

EOS-215 / iTeos ... EOS006215 as Monotherapy and in Combination With Pembrolizumab or Other Anticancer Treatments in Participants With Advanced Solid Tumors (clinicaltrials.gov) ...

3. synapse.patsnap.com synapse.patsnap.com/organization/201e15b723a32a51d6c648034824c8f0

iTeos Belgium SA - Drug pipelines, Patents, Clinical trials A First-in-Human Open-label, Phase I/Ib Dose Escalation and Expansion Cohort Study of EOS006215 as Monotherapy and in Combination With Pembrolizumab or ...

4. sec.gov sec.gov/Archives/edgar/data/1808865/000095017025004560/itos-ex99_1.pdf

Advancing Science. These forward-looking statements include statements relating to the potential benefits of our product candidates and combinations; our clinical, data generation ...

5. ckb.genomenon.com ckb.genomenon.com/reference/show/275

Reference Detail - CKB CORE - Genomenon This reference is often associated with concepts defined in CKB when other references are not available. For example, category variants, non-specific variants, ...

6. withpower.com withpower.com/trial/phase-1-neoplasms-2-2025-e5789

EOS006215 for Cancer · Info for Participants The safety data for similar treatments like erlotinib and gefitinib, which are also EGFR tyrosine kinase inhibitors, show that they are generally well tolerated ...

7. trialstoday.org trialstoday.org/trial/NCT06877533

A First-in-Human Open-label, Phase I/Ib Dose Escalation ... The study includes EOS006215 monotherapy and combination therapy with other anticancer agents in participants with advanced solid tumors.