Testing EOS006215 for advanced solid tumors
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 Other Anticancer Treatments in Participants With Advanced Solid Tumors
This study is testing a new drug called EOS006215 to see if it can safely help people with advanced solid tumors when used alone or with other cancer treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iTeos Therapeutics Industry-sponsored |
| Locations | 9 sites (Denver, Colorado and 8 other locations) |
| Trial ID | NCT06877533 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of EOS006215, a monoclonal antibody targeting TREM2. The study consists of two parts: a dose escalation phase to assess EOS006215 as a monotherapy and in combination with other anticancer treatments, followed by a dose expansion phase to further evaluate its efficacy and safety in participants with specific advanced solid tumors. Participants will be closely monitored for their response to the treatment and any side effects.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced or metastatic unresectable solid tumors who have not responded to standard treatments.
Not a fit: Patients with recent systemic anticancer treatment or those with planned major surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, but this specific treatment is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histologically or cytologically confirmed advanced or metastatic unresectable solid tumors for which standard approved treatment is not available or the participant is ineligible or did not tolerate the standard approved treatment. * At least one tumor lesion measurable per RECIST v1.1 * Have an estimated minimum life expectancy of ≥ 12 weeks. * Adequate organ/marrow and liver function * Agree to use adequate highly effective method of contraception during the study is mandatory, if WOCBP or male Exclusion Criteria: * Prior systemic anticancer treatment including investigational agents within 3 weeks (or 5 half-lives, whichever is shorter) before the first dose of study treatment * Major surgery planned or within 5 weeks before the first dose of study treatment, or minor surgical procedure (except tumor biopsy) within 7 days before the first dose of study treatment. * Radiotherapy within 2 weeks before the first dose of study treatment. * Evidence of severe active or chronic infections requiring systemic antibacterial, antiviral, or antifungal treatment, including tuberculosis infection * Known seropositivity for or active infection with human immunodeficiency virus (HIV) * Known seropositivity for hepatitis B virus (HBV), with evidence of active HBV infection * Known seropositivity for hepatitis C virus (HCV), with evidence of active HCV infection * Live or live-attenuated vaccine within 30 days before the first dose of study treatment. * History or current evidence of uncontrolled or significant cardiovascular disease * History or current evidence of significant autoimmune disease that required systemic * treatment * Diagnosis of immunodeficiency or any condition requiring systemic treatment with immunosuppressive medication * Pregnant or breastfeeding.
Where this trial is running
Denver, Colorado and 8 other locations
- Sarah Cannon Research Institute at HealthOne — Denver, Colorado, United States (Recruiting)
- Florida Cancer Specialists (FSC SAC DDU) Sarasota — Sarasota, Florida, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Not_yet_recruiting)
- SCRI Oncology Partners — Nashville, Tennessee, United States (Recruiting)
- MD Anderson — Houston, Texas, United States (Not_yet_recruiting)
- Institut Jules Bordet — Brussels, Belgium (Not_yet_recruiting)
- UZ Gent — Gent, Belgium (Not_yet_recruiting)
- UZ Leuven — Leuven, Belgium (Not_yet_recruiting)
- Cliniques Universitaires Saint-Luc — Woluwé-Saint-Lambert, Belgium (Not_yet_recruiting)
Study contacts
- Study coordinator: iTeos Belgium SA
- Email: clinical_info@iteostherapeutics.com
- Phone: + 32 71 91 99 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.