TERMINATED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-07
Study Completion:2025-07-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06877533

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  2. * 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.
  3. * At least one tumor lesion measurable per RECIST v1.1
  4. * Have an estimated minimum life expectancy of ≥ 12 weeks.
  5. * Adequate organ/marrow and liver function
  6. * Agree to use adequate highly effective method of contraception during the study is mandatory, if WOCBP or male
  1. * Prior systemic anticancer treatment including investigational agents within 3 weeks (or 5 half-lives, whichever is shorter) before the first dose of study treatment
  2. * 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.
  3. * Radiotherapy within 2 weeks before the first dose of study treatment.
  4. * Evidence of severe active or chronic infections requiring systemic antibacterial, antiviral, or antifungal treatment, including tuberculosis infection
  5. * Known seropositivity for or active infection with human immunodeficiency virus (HIV)
  6. * Known seropositivity for hepatitis B virus (HBV), with evidence of active HBV infection
  7. * Known seropositivity for hepatitis C virus (HCV), with evidence of active HCV infection
  8. * Live or live-attenuated vaccine within 30 days before the first dose of study treatment.
  9. * History or current evidence of uncontrolled or significant cardiovascular disease
  10. * History or current evidence of significant autoimmune disease that required systemic
  11. * treatment
  12. * Diagnosis of immunodeficiency or any condition requiring systemic treatment with immunosuppressive medication
  13. * Pregnant or breastfeeding.

Contacts and Locations

Principal Investigator

iTeos Belgium SA
STUDY_DIRECTOR
iTeos Belgium SA

Study Locations (Sites)

Sarah Cannon Research Institute at HealthOne
Denver, Colorado, 80218
United States
Florida Cancer Specialists (FSC SAC DDU) Sarasota
Sarasota, Florida, 24232
United States

Collaborators and Investigators

Sponsor: iTeos Belgium SA

  • iTeos Belgium SA, STUDY_DIRECTOR, iTeos Belgium SA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-07
Study Completion Date2025-07-10

Study Record Updates

Study Start Date2025-04-07
Study Completion Date2025-07-10

Terms related to this study

Keywords Provided by Researchers

  • Advanced solid tumors
  • Cancer
  • Phase I
  • Immunotherapy
  • Anticancer
  • Anti-PD1
  • TREM2
  • Pembrolizumab
  • EOS-215
  • Metastatic
  • Antibodies
  • Monoclonal antibodies
  • Antineoplastic therapy
  • EOS006215

Additional Relevant MeSH Terms

  • Selected Advanced Solid Tumors