Clinical trial · Interventional
Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC
A Phase 1/2 Study of HDAC Inhibitor, Mocetinostat, in Combination With PD-L1 Inhibitor, Durvalumab, in Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was discontinued early because the Sponsor de-prioritized development of mocetinostat. The decision to stop was not due to any patient safety issues.
Summary
Brief summary (as posted)
Mocetinostat (MGCD0103) is an orally administered HDAC inhibitor. Durvalumab (MEDI4736) is a human monoclonal antibody that is an inhibitor of the Programmed Cell Death Ligand (or PD-L1). Durvalumab is also known as a checkpoint inhibitor. This study is evaluating the combination regimen of mocetinostat and durvalumab in participants with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer.
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 |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab - 1500 mg | Drug | Durvalumab | ALIAS |
| Mocetinostat - 50 mg | Drug | Mocetinostat | ALIAS |
| Mocetinostat - 70 mg | Drug | Mocetinostat | ALIAS |
| Mocetinostat - 90 mg | Drug | Mocetinostat | ALIAS |
| Mocetinostat - Recommended Phase 2 Dose (70 mg) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Phase 1: Dose Escalation - 50 mg
- description
- The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
- interventionNames
- Drug: Mocetinostat - 50 mg
- Drug: Durvalumab - 1500 mg
- type
- EXPERIMENTAL
- label
- Phase 1: Dose Escalation - 70 mg
- description
- The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
- interventionNames
- Drug: Mocetinostat - 70 mg
- Drug: Durvalumab - 1500 mg
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Phase 1-Diagnosis of advanced or metastatic solid tumor; Phase 2-Diagnosis of NSCLC * Not amenable to treatment with curative intent * Adequate bone marrow and organ function Exclusion Criteria: * Impaired heart function * Uncontrolled tumor in the brain * Other active cancer
References
Publications (0)
Data not yet available