Clinical trial · Interventional
Study of Mogamulizumab + MEDI4736 (Durvalumab) and Mogamulizumab + Tremelimumab in Subjects w/ Advanced Solid Tumors
Phase 1 Study of Mogamulizumab (KW-0761) in Combination With MEDI4736 (Durvalumab) and Mogamulizumab in Combination With Tremelimumab in Subjects With Advanced Solid Tumors
NCT02301130CI-TRIAL-00076460completedPhase 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)
Mogamulizumab in Combination with MEDI4736 (Durvalumab) and Mogamulizumab in Combination with Tremelimumab in 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 |
|---|---|---|---|
| MEDI4736 (Durvalumab) | Biological | Durvalumab | ALIAS |
| mogamulizumab | Biological | Mogamulizumab | ALIAS |
| tremelimumab | Biological | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- mogamulizumab + MEDI4736 (Durvalumab)
- description
- During Parts 1 and 2, mogamulizumab and MEDI4736 (Durvalumab) are administered at appropriate intervals. Part 1 (Dose Escalation Phase) \- During Cohort 1A to 4A, increased doses of mogamulizumab and MEDI4736 (Durvalumab) are administered. Part 2 (Cohort Expansion Phase) * Patients will be treated with maximum tolerated dose established in the Dose Escalation Phase for each combination.
- interventionNames
- Biological: mogamulizumab
- Biological: MEDI4736 (Durvalumab)
- type
- EXPERIMENTAL
- label
- mogamulizumab + tremelimumab
- description
- During Parts 1 and 2, mogamulizumab and tremelimumab are administered at appropriate intervals. Part 1 (Dose Escalation Phase) \- During Cohort 1B to 4B, increased doses of mogamulizumab and tremelimumab are administered. Part 2 (Cohort Expansion Phase) * Patients will be treated with maximum tolerated dose established in the Dose Escalation Phase for each combination.
- interventionNames
- Biological: mogamulizumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years; * Locally advanced or metastatic solid tumors; * Histologically or cytologically confirmed disease; * Failed or were intolerant to at least one prior systemic treatment regimen with oral or IV medications and have no additional therapy options known to prolong survival with the exception of PD-1 or PD-L1 blockade therapy for subjects who will be enrolled in treatment arm A. Subjects with non-small cell lung cancer must have received at least one platinum doublet regimen. Subjects with known epidermal growth factor receptor tyrosine kinase inhibitor activating mutations or anaplastic lymphoma kinase rearrangement must have also exhausted approved targeted therapy options; * The subject has a tumor suitable for biopsy and is willing to undergo tumor biopsy, preferably of the primary tumor, within 28 days prior to Cycle 1/Visit Day 1; Exclusion Criteria: * Any concurrent chemotherapy, biologic, hormonal, radiation, or investigative therapy for cancer treatment within 21 days prior prior or within 6 weeks prior to Cycle 1/Visit Day 1 for nitrosoureas or mitomycin C; * Concurrent or prior use of immunosuppressive medication within 28 days; * Active or prior documented autoimmune, or inflammatory bowel disease, or inflammatory bowel disease. or systemic treatment for psoriasis within the past 5 years.; * Prior hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins, or immunotherapy.
References
Publications (1)
- DERIVEDZamarin D, Hamid O, Nayak-Kapoor A, Sahebjam S, Sznol M, Collaku A, Fox FE, Marshall MA, Hong DS. Mogamulizumab in Combination with Durvalumab or Tremelimumab in Patients with Advanced Solid Tumors: A Phase I Study. Clin Cancer Res. 2020 Sep 1;26(17):4531-4541. doi: 10.1158/1078-0432.CCR-20-0328. Epub 2020 Jun 25. PMID 32586937