EOS006215 for Cancer

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

94 Participants Needed

Trial Summary

What is the purpose of this trial?

TRM-010 is a first-in-human (FIH) clinical study designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of EOS006215, a fully human monoclonal antibody that binds to the triggering receptor expressed on myeloid cells 2 (TREM2). The study includes EOS006215 monotherapy and combination therapy with other anticancer agents in participants with advanced solid tumors.

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.

What safety data exists for EOS006215 in humans?

The safety data for similar treatments like erlotinib and gefitinib, which are also EGFR tyrosine kinase inhibitors, show that they are generally well tolerated in humans. Common side effects include mild skin and gastrointestinal issues, while more serious side effects like pulmonary toxicity and sepsis are rare. ^{1 2 3 4 5}

How does the drug EOS006215 differ from other cancer treatments?

EOS006215 is unique because it targets the epidermal growth factor receptor (EGFR), which is often overexpressed in many cancers, including non-small cell lung cancer and colon cancer. This drug likely works by blocking the EGFR pathway, similar to other EGFR inhibitors like C225 and ZD1839, which have shown effectiveness in combination with chemotherapy and radiation. ^{6 7 8 9 10}

Research Team

iTeos Belgium SA

Principal Investigator

iTeos Belgium SA

Eligibility Criteria

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

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

At least one tumor lesion measurable per RECIST v1.1

Have an estimated minimum life expectancy of ≥ 12 weeks

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

High Prevalence and Early Occurrence of Skeletal Complications in EGFR Mutated NSCLC Patients With Bone Metastases. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

A benefit-risk assessment of erlotinib in non-small-cell lung cancer and pancreatic cancer. [2021]

3. France pubmed.ncbi.nlm.nih.gov

Gefitinib (Iressa, ZD1839): a novel targeted approach for the treatment of solid tumors. [2018]

4. England pubmed.ncbi.nlm.nih.gov

A review of erlotinib and its clinical use. [2019]

5. England 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. [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

The epidermal growth factor receptor pathway and its inhibition as anticancer therapy. [2022]

7. China pubmed.ncbi.nlm.nih.gov

[Effect of KRAS mutation on efficacy of Cetuximab combined with chemotherapy in advanced colorectal cancer patients]. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

A window of opportunity study of potential tumor and soluble biomarkers of response to preoperative erlotinib in early stage non-small cell lung cancer. [2018]

9. England pubmed.ncbi.nlm.nih.gov

The epidermal growth factor receptor as a target for cancer therapy. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of gefitinib (Iressa) on mammary cancers: preventive studies with varied dosages, combinations with vorozole or targretin, and biomarker changes. [2020]