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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-520369-30-00 | EU Trial (CTIS) Number |
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The study was terminated early due to sponsor's strategic business decision.
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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.
The study will be conducted in 2 parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Dose Escalation (Monotherapy) | Experimental | EOS006215 dose escalation as monotherapy |
|
| Part 1 Dose Escalation (Combination Therapy) | Experimental | EOS006215 dose escalation in combination with pembrolizumab or with other anticancer agents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EOS006215 | Drug | Multiple doses of EOS006215 |
|
| Measure | Description | 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| iTeos Belgium SA | iTeos Belgium SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon Research Institute at HealthOne | Denver | Colorado | 80218 | United States | ||
| Florida Cancer Specialists (FSC SAC DDU) Sarasota |
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| Anticancer agent | Drug | Multiple doses of EOS006215 in combination with other anticancer agents |
|
| 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 |
| Sarasota |
| Florida |
| 24232 |
| United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000970 | Antineoplastic Agents |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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