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

Launched by ITEOS BELGIUM SA · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called EOS006215, which is a type of medication designed to help people with advanced solid tumors, which are cancers that can no longer be removed with surgery. The trial is looking to see how safe EOS006215 is, how well it works on tumors, and how it interacts with other cancer treatments like Pembrolizumab. This is the first time EOS006215 is being tested in humans, and researchers are particularly interested in understanding its effects when given alone or in combination with other therapies.

To participate in this study, individuals should have certain types of advanced cancer that have not responded to standard treatments or for which no standard treatments are available. Eligible participants must be between 18 and 75 years old, have a good performance status (meaning they are fairly active), and have at least one measurable tumor. Those with recent treatments, major surgeries, or certain health conditions may not be eligible. Participants can expect regular check-ups and monitoring throughout the trial to ensure their safety and to track how well the treatment is working.

Gender

ALL

Eligibility criteria

• 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.