Selected Advanced Solid TumorsPhase 1NCT06877533
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
A Phase 1 study testing EOS006215 and Anticancer agent in people with Selected Advanced Solid Tumors, run by iTeos Belgium SA at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Selected Advanced Solid Tumors
- What is being tested?
- EOS006215 and Anticancer agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Apr 2025to 10 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, 80218
Florida Cancer Specialists (FSC SAC DDU) Sarasota
Sarasota, Florida, 24232
About this study
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.
Read the 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.
- Conditions
- Selected Advanced Solid Tumors
- Being tested
- EOS006215, Anticancer agent
- Keywords
- Advanced solid tumors, Cancer, Phase I, Immunotherapy, Anticancer, Anti-PD1, TREM2, Pembrolizumab, EOS-215, Metastatic, Antibodies, Monoclonal antibodies, Antineoplastic therapy, EOS006215
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS006215Drug
Multiple doses of EOS006215
Anticancer agentDrug
Multiple doses of EOS006215 in combination with other anticancer agents
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose Escalation (Monotherapy) | Experimental | EOS006215 dose escalation as monotherapy Receives: Drug: EOS006215 |
| Part 1 Dose Escalation (Combination Therapy) | Experimental | EOS006215 dose escalation in combination with pembrolizumab or with other anticancer agents Receives: Drug: EOS006215; Drug: Anticancer agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs), adverse events (AEs)/serious adverse events (SAEs) [Safety and Tolerability]
Measured: 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]
Measured: Duration of intervention (up to 24 months)
Changes in safety parameters (clinical laboratory tests, vital signs, and electrocardiogram [ECG] / QTcF) [Safety and Tolerability]
Measured: Duration of intervention (up to 24 months) plus 30 days follow-up
Secondary outcomes (6)
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
Measured: From randomization to confirmed radiological improvement, if applicable, assessed up to 24 months.
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.
Measured: 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]
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Duration of intervention (up to 24 months) plus 30 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start7 Apr 2025
- Primary completion10 Jul 2025
- Study completion10 Jul 2025
Why it stopped: The study was terminated early due to sponsor's strategic business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Selected Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- iTeos Belgium SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- iTeos Belgium SA, Study director, iTeos Belgium SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877533
- Sponsor's protocol ID
- TRM-010
- Other IDs
- 2024-520369-30-00
- Status last verified
- Aug 2025
- First submitted
- 10 Mar 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06877533
- Acronym / sponsor ID
- TRM-010
- Conditions
- Selected Advanced Solid Tumors
- Keywords
- Advanced solid tumors, Cancer, Phase I, Immunotherapy, Anticancer, Anti-PD1, TREM2, Pembrolizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to sponsor's strategic business decision.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- iTeos Belgium SAIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Escalation (Monotherapy) | Experimental | Drug: EOS006215EOS006215 dose escalation as monotherapy |
| Part 1 Dose Escalation (Combination Therapy) | Experimental | Drug: EOS006215, Drug: Anticancer agentEOS006215 dose escalation in combination with pembrolizumab or with other anticancer agents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EOS006215Multiple doses of EOS006215 | Drug | Part 1 Dose Escalation (Combination Therapy), Part 1 Dose Escalation (Monotherapy) |
| Anticancer agentMultiple doses of EOS006215 in combination with other anticancer agents | Drug | Part 1 Dose Escalation (Combination Therapy) |
Primary outcome
Incidence of dose-limiting toxicities (DLTs), adverse events (AEs)/serious adverse events (SAEs) [Safety and Tolerability]
Time frame: 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]
Time frame: Duration of intervention (up to 24 months)
Changes in safety parameters (clinical laboratory tests, vital signs, and electrocardiogram [ECG] / QTcF) [Safety and Tolerability]
Time frame: Duration of intervention (up to 24 months) plus 30 days follow-up
6 secondary outcomes
Overall response rate (ORR) [Efficacy]
Time frame: From randomization to confirmed radiological improvement, if applicable, assessed up to 24 months.
Duration of response (DoR)
Time frame: 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 frame: Time from starting treatment until disease progression or death for any reason.
Serum concentrations and PK parameters of EOS006215
Time frame: From start of treatment until end of treatment (EOT)
Incidence of antidrug antibody (ADA) against EOS006215
Time frame: From start of treatment until end of treatment (EOT)
Dose-finding to determine recommended Phase 2 dose
Time frame: Duration of intervention (up to 24 months) plus 30 days follow-up
Results and safety
The study was stopped early (reason given: The study was terminated early due to sponsor's strategic business decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
iTeos Belgium SA study director
iTeos Belgium SA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EOS006215 and Anticancer agent in people with Selected Advanced Solid Tumors, run by iTeos Belgium SA at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early due to sponsor's strategic business decision.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs), adverse events (AEs)/serious adverse events (SAEs) [Safety and Tolerability] (time frame: DLTs - At the end of Cycle 1 AEs/SAES - Duration of intervention (up to 24 months) plus 30 days follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025; AzTrials last refreshed its copy on 30 Oct 2026.