Clinical trial · Interventional
A Study of MEDI9253 in Combination With Durvalumab in Select Solid Tumors
An Open-label, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MEDI9253, a Recombinant Newcastle Disease Virus Encoding Interleukin-12, in Combination With Durvalumab in Participants With Select Advanced/Metastatic Solid Tumors
- 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 terminated early due to lack of efficacy and absence of biomarker evidence of MEDI9253's impact on the tumors.
Summary
Brief summary (as posted)
Study D7880C00001 is a first-in-human (FIH), Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of MEDI9253 in combination with durvalumab in adult participants with select advanced/metastatic 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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Biological | Durvalumab | ALIAS |
| MEDI9253 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- MEDI9253 Single Dose Level 1 + Durvalumab 1500 mg Q4W
- description
- Participants will receive intravenous (IV) infusion of a single dose of MEDI9253 dose level 1 on Day 1. After 14 days (+7 days) of MEDI9253 dose, participants will receive IV durvalumab at 1500 mg once every 4 weeks (Q4W) until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity, for up to 2 years.
- interventionNames
- Biological: MEDI9253
- Biological: Durvalumab
- type
- EXPERIMENTAL
- label
- MEDI9253 Single Dose Level 2 + Durvalumab 1500 mg Q4W
- description
- Participants will receive IV infusion of a single dose of MEDI9253 dose level 2 on Day 1. After 14 days (+7 days) of MEDI9253 dose, participants will receive IV durvalumab at 1500 mg Q4W until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity, for up to 2 years.
- interventionNames
- Biological: MEDI9253
- Biological: Durvalumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 101 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participant must be at least 18 years old at signing of informed consent. 2. Body weight \> 35 kg at screening. Exclusion Criteria: 1 Primary central nervous system (CNS) disease is excluded, as well as untreated or uncontrolled metastatic CNS involvement, leptomeningeal disease, or cord compression. NOTE: CNS disease that has been treated and stable/controlled for at least 3 months is permitted. Participants with CNS disease controlled via systemic steroids are not permitted.
References
Publications (0)
Data not yet available