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

Last updated: April 8, 2025
Sponsor: iTeos Belgium SA
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

EOS006215

Anticancer agent

Clinical Study ID

NCT06877533
TRM-010
2024-520369-30-00
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Histologically or cytologically confirmed advanced or metastatic unresectable solidtumors for which standard approved treatment is not available or the participant isineligible 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 ismandatory, if WOCBP or male

Exclusion

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, orminor surgical procedure (except tumor biopsy) within 7 days before the first doseof 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 HBVinfection

  • Known seropositivity for hepatitis C virus (HCV), with evidence of active HCVinfection

  • Live or live-attenuated vaccine within 30 days before the first dose of studytreatment.

  • 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 withimmunosuppressive medication

  • Pregnant or breastfeeding.

Study Design

Total Participants: 94
Treatment Group(s): 2
Primary Treatment: EOS006215
Phase: 1
Study Start date:
April 07, 2025
Estimated Completion Date:
May 31, 2027

Study Description

The study will be conducted in 2 parts:

  • Part 1 - Dose Escalation Phase I dose escalation cohorts for EOS006215 as monotherapy and in combination with anticancer treatments in participants with specific tumor types.

  • Part 2 - Dose Expansion Phase Ib dose expansion cohort(s) may be included to further evaluate the safety, tolerability, efficacy, PK and PD of EOS006215 as monotherapy or in combination with anticancer treatments in participants with specific tumor types.

Connect with a study center

  • Institut Jules Bordet

    Brussels, 1070
    Belgium

    Site Not Available

  • UZ Gent

    Gent, 9000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Woluwé-Saint-Lambert, 1200
    Belgium

    Site Not Available

  • Sarah Cannon Research Institute at HealthOne

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Florida Cancer Specialists (FSC SAC DDU) Sarasota

    Sarasota, Florida 24232
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • MD Anderson

    Houston, Texas 77030
    United States

    Site Not Available

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