Clinical trial · Interventional
New Formulation Study of Inupadenant (EOS100850) in Patients with Cancer
A Multicenter, Open-Label, Phase I Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Food-Effect of Inupadenant New Formulations in Participants with Advanced Solid Tumors
NCT05117177CI-TRIAL-00080715completedPhase 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)
A2A-004 is a three-part multicenter, open-label, Phase I clinical trial intended to evaluate the safety and tolerability, and the pharmacokinetics (PK) and food effect of new formulations of inupadenant (formerly known as EOS100850), in participants with advanced solid tumors.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inupadenant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Inupadenant sequential dose escalation (Part 1A)
- description
- Part 1A will evaluate the safety as well as to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of inupadenant in participants with advanced solid tumors.
- interventionNames
- Drug: Inupadenant
- type
- EXPERIMENTAL
- label
- Inupadenant randomized crossover (Part 1B)
- description
- The effect of food on the exposure to inupadenant will be investigated in participants with advanced solid tumors.
- interventionNames
- Drug: Inupadenant
- type
- EXPERIMENTAL
- label
- Inupadenant single treatment assignment (Part 1C)
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.