Clinical trial · Interventional
MEDI5083 Alone and in Combination With Durvalumab, Tremelimumab, and/or Docetaxel.
A Phase 1 First Time in Human Study to Evaluate the Safety, Pharmacokinetics and Immunogenicity of MEDI5083 Alone or in Combination With Durvalumab, Tremelimumab, and/or Docetaxel in Advanced Solid Tumors
NCT03089645CI-TRIAL-00046207completedPhase 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)
The purpose of this study is to evaluate the safety, pharmacokinetics and Immunogenicity of Medi5083 alone or in combination with Durvalumab,Tremelimumab, and/or Docetaxel in adult subjects 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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEDI5083 monotherapy | Biological | — | UNRESOLVED |
| Medi5083 with Durvalumab and Docetaxel | Biological | — | UNRESOLVED |
| MEID5083 with Durvalumab or Tremelimumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part 1
- description
- MEDI5083 monotherapy followed by Durvalumab monotherapy in subjects with advanced solid tumors
- interventionNames
- Biological: MEDI5083 monotherapy
- type
- EXPERIMENTAL
- label
- Part 2
- description
- Sequential MEDI5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab in subjects with advanced solid tumors.
- interventionNames
- Biological: MEID5083 with Durvalumab or Tremelimumab
- type
- EXPERIMENTAL
- label
- Part 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 101 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years at the time of screening or age of consent according to local law 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 3. Histologically or cytologically confirmed metastatic or recurrent tumor types 4. Subjects who have received prior immunotherapy may be eligible 5. Subjects must have at least one measurable lesion 6. Consent to provide archival tumor tissue and pre/on-treatment biopsies 7. Adequate organ and marrow function 8. Consent to use one highly effective method of contraception Exclusion Criteria: 1. Receipt of any systemic anticancer therapy within 28 days prior to the first dose of MEDI5083 2. Concurrent enrollment in another clinical study 3. Active/prior autoimmune of inflammatory disorders 4. History of immunodeficiency, solid organ transplant, or tuberculosis 5. Known allergy/hypersensitivity to drug or components 6. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression 7. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI5083
References
Publications (0)
Data not yet available
No reference posted for this study.