Clinical trial NCT06877533: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
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
Lead sponsor: iTeos Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-03-14
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of dose-limiting toxicities (DLTs), adverse events (AEs)/serious adverse events (SAEs) [Safety and Tolerability]
timeFrame: DLTs - At the end of Cycle 1 AEs/SAES - Duration of intervention (up to 24 months) plus 30 days follow-up
measure: Rate of treatment modifications (interruption or permanent discontinuation) [Safety and Tolerability]
timeFrame: Duration of intervention (up to 24 months)
measure: Changes in safety parameters (clinical laboratory tests, vital signs, and electrocardiogram [ECG] / QTcF) [Safety and Tolerability]
timeFrame: Duration of intervention (up to 24 months) plus 30 days follow-up
Secondary outcomes:
measure: Overall response rate (ORR) [Efficacy]
timeFrame: From randomization to confirmed radiological improvement, if applicable, assessed up to 24 months.
measure: Duration of response (DoR)
timeFrame: 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.
measure: Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Efficacy]
timeFrame: Time from starting treatment until disease progression or death for any reason.
measure: Serum concentrations and PK parameters of EOS006215
timeFrame: From start of treatment until end of treatment (EOT)
measure: Incidence of antidrug antibody (ADA) against EOS006215
timeFrame: From start of treatment until end of treatment (EOT)
measure: Dose-finding to determine recommended Phase 2 dose
timeFrame: Duration of intervention (up to 24 months) plus 30 days follow-up
Other outcomes:
Locations:
city: Denver
country: United States
facility: Sarah Cannon Research Institute at HealthOne
state: Colorado
city: Sarasota
country: United States
facility: Florida Cancer Specialists (FSC SAC DDU) Sarasota
state: Florida
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Woluwé-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: iTeos Belgium SA
name: iTeos Belgium SA
role: STUDY_DIRECTOR
References: