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

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: Terminated
• Conditions: Selected Advanced Solid Tumors
• Intervention / Treatment: Drug: EOS006215; Drug: Anticancer agent

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: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Incidence of dose-limiting toxicities (DLTs), adverse events (AEs)/serious adverse events (SAEs) [Safety and Tolerability]	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]	Duration of intervention (up to 24 months)
Changes in safety parameters (clinical laboratory tests, vital signs, and electrocardiogram [ECG] / QTcF) [Safety and Tolerability]	Duration of intervention (up to 24 months) plus 30 days follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR) [Efficacy]	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 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 from starting treatment until disease progression or death for any reason.
Serum concentrations and PK parameters of EOS006215	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	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	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

• Sponsor: iTeos Belgium SA
• Investigators: Study Director: iTeos Belgium SA, iTeos Belgium SA

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Actual): July 10, 2025
• Study Completion (Actual): July 10, 2025

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 14, 2025

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Immunotherapy; Pembrolizumab; Phase I; Metastatic; Antibodies; Anti-PD1; Monoclonal antibodies; Advanced solid tumors; Anticancer; TREM2; EOS-215; Antineoplastic therapy; EOS006215
• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents
• Other Study ID 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