Clinical trial · Interventional
A Phase 1 Study of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors
NCT02318394CI-TRIAL-00031411completedPhase 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)
To evaluate the safety and tolerability of MEDI0562 in adult subjects with selected 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEDI0562 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Monotherapy Arm
- description
- MEDI0562 monotherapy
- interventionNames
- Biological: MEDI0562
Primary outcomes (1)
- measure
- Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
- timeFrame
- From time of informed consent through 12 weeks after last dose of MEDI0562
- description
- The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
Secondary outcomes (8)
- measure
- Objective response rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must have confirmed advanced solid tumor and have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type. Subjects should not have received more than 3 prior lines of therapy for recurrent or metastatic disease including both standards of care and investigational therapies. * Subjects must have at least 1 measurable lesion. * Consent to provide archived tumor specimens * Willingness to undergo pre-treatment and on-treatment biopsy. * Adequate organ function. * Use of highly effective contraception (females) or male condom plus spermicide (males). Exclusion Criteria: * Prior treatment with TNFRSF agonists. * Subjects who have received certain prior immunotherapy or had toxicities relating to prior immunotherapy may not be permitted to enroll. o Must not have required the use of additional immunosuppression other than corticosteroids for the management of an adverse event. * History of severe allergic reactions to any unknown allergens or any components of the study drug formulations. * Receipt of any conventional or investigational anticancer therapy within 28 days prior to the first dose of MEDI0562. * Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment. * Unresolved toxicities from prior anticancer therapy. * Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.
References
Publications (1)
- DERIVEDGlisson BS, Leidner RS, Ferris RL, Powderly J, Rizvi NA, Keam B, Schneider R, Goel S, Ohr JP, Burton J, Zheng Y, Eck S, Gribbin M, Streicher K, Townsley DM, Patel SP. Safety and Clinical Activity of MEDI0562, a Humanized OX40 Agonist Monoclonal Antibody, in Adult Patients with Advanced Solid Tumors. Clin Cancer Res. 2020 Oct 15;26(20):5358-5367. doi: 10.1158/1078-0432.CCR-19-3070. Epub 2020 Aug 14. PMID 32816951