Clinical trial · Interventional
First-in-Human Study of EOS100850 (Inupadenant) in Patients with Cancer
Phase I/Ib First-in-Human Study of EOS100850 (Inupadenant) As a Single Agent and in Combination with Pembrolizumab And/or Chemotherapy in Participants with Advanced Cancers
NCT03873883CI-TRIAL-00080630IO-001completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multicenter, open-label, dose-escalation Phase I/Ib clinical study to evaluate the safety and tolerability, the MTD/RP2D, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of EOS100850 (Inupadenant) as a Single Agent and in Combination with Pembrolizumab and/or Chemotherapy in Participants with Advanced Cancers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| EOS100850 | Drug | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- 1A Dose escalation EOS100850
- description
- Dose Escalation- EOS100850 Monotherapy: to confirm RP2D
- interventionNames
- Drug: EOS100850
- type
- EXPERIMENTAL
- label
- 1B Dose escalation EOS100850 and Pembrolizumab
- description
- EOS100850 and Pembrolizumab Combination Therapy: to confirm RP2D as combination
- interventionNames
- Drug: EOS100850
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
- 2A Dose Expansion- EOS100850
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding participation in the Trial, please refer to your physician Inclusion Criteria: * Women and men ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Subject with histologically or cytologically confirmed advanced solid tumor for whom no standard treatment is further available. * At least 4 weeks since any previous treatment for cancer * Subject must consent to pretreatment and on treatment tumor biopsies * Adequate organ and marrow function Exclusion Criteria: * Patients with primary brain tumors or primary tumors with central nervous system metastases as only location of disease. Controlled brain metastases are permitted * Participants with second/other active cancers requiring current treatment * Uncontrolled/significant heart disease * Known History of chronic hepatitis, Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except participants with liver cancer) or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS) * Active/uncontrolled autoimmune disease * Active infection Other protocol defined inclusion/exclusion criteria could apply
References
Publications (0)
Data not yet available
No reference posted for this study.