Selected Advanced Solid Tumors
Conditions
Keywords
Advanced solid tumors, Cancer, Phase I, Immunotherapy, Anticancer, Anti-PD1, TREM2, Pembrolizumab, EOS-215, Metastatic, Antibodies, Monoclonal antibodies, Antineoplastic therapy, EOS006215
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.
Interventions
DRUGEOS006215
Multiple doses of EOS006215
DRUGAnticancer agent
Multiple doses of EOS006215 in combination with other anticancer agents
Sponsors
iTeos Belgium SA
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| Serum concentrations and PK parameters of EOS006215 | 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. |
| Overall response rate (ORR) [Efficacy] | 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 |
| Dose-finding to determine recommended Phase 2 dose | 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. |
| Incidence of antidrug antibody (ADA) against EOS006215 | 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. |
| 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. | 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. |
| 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. | — |
Countries
United States
Outcome results
None listed