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

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.

Conditions

Selected Advanced Solid Tumors

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Selected Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Denver

Sarah Cannon Research Institute at HealthOne, Denver, Colorado, United States, 80218

Sarasota

Florida Cancer Specialists (FSC SAC DDU) Sarasota, Sarasota, Florida, United States, 24232

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Nashville

SCRI Oncology Partners, Nashville, Tennessee, United States, 37203

Houston

MD Anderson, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

iTeos Belgium SA,

iTeos Belgium SA, STUDY_DIRECTOR, iTeos Belgium SA

Study Record Dates

2027-05