Status:
TERMINATED
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
Lead Sponsor:
iTeos Belgium SA
Conditions:
Selected Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 hum...
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 spec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT06877533
Start Date
April 7 2025
End Date
July 10 2025
Last Update
August 12 2025
Active Locations (2)
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1
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, United States, 80218
2
Florida Cancer Specialists (FSC SAC DDU) Sarasota
Sarasota, Florida, United States, 24232