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

iTeos Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Selected Advanced Solid Tumors

Treatments: Drug: Anticancer agent; Drug: EOS006215

Study type: Interventional

Funder types: Industry

Identifiers

NCT06877533

2024-520369-30-00 (EU Trial (CTIS) Number)

TRM-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

3 participants in 2 patient groups

Part 1 Dose Escalation (Monotherapy)

Experimental group

Description:

EOS006215 dose escalation as monotherapy

Treatment:

Drug: EOS006215

Part 1 Dose Escalation (Combination Therapy)

Experimental group

Description:

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

Treatment:

Drug: EOS006215

Drug: Anticancer agent