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

NCT06877533 | Terminated Phase 1 FDA Drug

• 2 other identifiers: TRM-0102024-520369-30-00
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Selected Advanced Solid Tumors

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Overall response rate (ORR) [Efficacy]

  From randomization to confirmed radiological improvement, if applicable, assessed up to 24 months.

• Duration of response (DoR)

  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

  From start of treatment until end of treatment (EOT)

• Incidence of antidrug antibody (ADA) against EOS006215

  From start of treatment until end of treatment (EOT)

Study Arms (2)

Part 1 Dose Escalation (Monotherapy)

EXPERIMENTAL

EOS006215 dose escalation as monotherapy

Drug: EOS006215

Part 1 Dose Escalation (Combination Therapy)

EXPERIMENTAL

EOS006215 dose escalation in combination with pembrolizumab or with other anticancer agents

Drug: EOS006215; Drug: Anticancer agent

Interventions

EOS006215 DRUG

Multiple doses of EOS006215

Part 1 Dose Escalation (Combination Therapy); Part 1 Dose Escalation (Monotherapy)

Anticancer agent DRUG

Multiple doses of EOS006215 in combination with other anticancer agents

Part 1 Dose Escalation (Combination Therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• iTeos Belgium SA: lead

Study Sites (2)

Sarah Cannon Research Institute at HealthOne

Denver, Colorado, 80218, United States

Location

Florida Cancer Specialists (FSC SAC DDU) Sarasota

Sarasota, Florida, 24232, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

Antineoplastic Agents

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• iTeos Belgium SA

  iTeos Belgium SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: April 7, 2025
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)