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

August 7, 2025 updated by: iTeos Belgium SA
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1 Dose Escalation (Monotherapy)
EOS006215 dose escalation as monotherapy
Drug: EOS006215
Multiple doses of EOS006215
Experimental: Part 1 Dose Escalation (Combination Therapy)
EOS006215 dose escalation in combination with pembrolizumab or with other anticancer agents
Drug: EOS006215
Multiple doses of EOS006215
Drug: Anticancer agent
Multiple doses of EOS006215 in combination with other anticancer agents

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of dose-limiting toxicities (DLTs), adverse events (AEs)/serious adverse events (SAEs) [Safety and Tolerability]
Time Frame: DLTs - At the end of Cycle 1 AEs/SAES - Duration of intervention (up to 24 months) plus 30 days follow-up
DLTs - At the end of Cycle 1 AEs/SAES - Duration of intervention (up to 24 months) plus 30 days follow-up
Rate of treatment modifications (interruption or permanent discontinuation) [Safety and Tolerability]
Time Frame: Duration of intervention (up to 24 months)
Duration of intervention (up to 24 months)
Changes in safety parameters (clinical laboratory tests, vital signs, and electrocardiogram [ECG] / QTcF) [Safety and Tolerability]
Time Frame: Duration of intervention (up to 24 months) plus 30 days follow-up
Duration of intervention (up to 24 months) plus 30 days follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) [Efficacy]
Time Frame: From randomization to confirmed radiological improvement, if applicable, assessed up to 24 months.
Proportion of participants with Best Overall Response (BOR) of complete response (CR) or partial response (PR) confirmed at a minimum of 2 post-baseline radiological assessments, without an intervening response of progressive disease
From randomization to confirmed radiological improvement, if applicable, assessed up to 24 months.
Duration of response (DoR)
Time Frame: From first confirmed CR or PR (whichever is first recorded) until the date of documented disease progression or death in the absence of disease progression, assessed up to 24 months.
Time from the date of first confirmed CR or PR (whichever is first recorded) until the date of documented disease progression or death in the absence of disease progression.
From first confirmed CR or PR (whichever is first recorded) until the date of documented disease progression or death in the absence of disease progression, assessed up to 24 months.
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Efficacy]
Time Frame: Time from starting treatment until disease progression or death for any reason.
Time from starting treatment until disease progression or death for any reason.
Serum concentrations and PK parameters of EOS006215
Time Frame: From start of treatment until end of treatment (EOT)
Serum concentration-time data will be summarized by descriptive statistics by each treatment cohort and time point. PK parameters, such as Cmax, Cmin, AUC and CL will be derived by non-compartmental analysis and summarized with descriptive statistics.
From start of treatment until end of treatment (EOT)
Incidence of antidrug antibody (ADA) against EOS006215
Time Frame: From start of treatment until end of treatment (EOT)
Individual ADA occurrence will be listed, and percentage of occurrence will be summarized by descriptive statistics.
From start of treatment until end of treatment (EOT)
Dose-finding to determine recommended Phase 2 dose
Time Frame: Duration of intervention (up to 24 months) plus 30 days follow-up
The RP2D(s) will be identified from the available safety, tolerability, PK, PD and preliminary efficacy data across the dose ranges evaluated in monotherapy and in combination with anticancer agents.
Duration of intervention (up to 24 months) plus 30 days follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
iTeos Belgium SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: iTeos Belgium SA, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRM-010
  • 2024-520369-30-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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