Clinical trial · Interventional
A Study in Adult Subjects With Select Advanced Solid Tumors
A Phase 1 Study of MEDI1873 (GITR Agonist) in Adult Subjects With Select Advanced Solid Tumors
NCT02583165CI-TRIAL-00036404completedPhase 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 MEDI1873 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 |
|---|---|---|---|
| MEDI1873 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Monotherapy arm
- description
- MEDI1873
- interventionNames
- Biological: MEDI1873
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 months after last dose of MEDI1873
- description
- The maximum tolerated dose (MTD)/highest protocol-defined dose level in the absence of establishing an MTD will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, DLTs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
Secondary outcomes (12)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All subjects must consent to provide archived tumor specimen * Subjects must have histologically or cytologically confirmed advanced solid tumor for recurrent or metastatic disease. * At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated and must be asymptomatic * Willingness to provide pretreatment and on-treatment biopsies. * Adequate organ function * Females of childbearing potential and nonsterilized males who are sexually active must use effective methods of contraception Exclusion Criteria: * Known allergic reaction to any component of MEDI1873 * Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study * Receipt of any anticancer therapy within 4 weeks prior to the first dose of MEDI1873; in the case of mAbs, 6 weeks prior to the first dose of MEDI1873 * Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. * Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational product * 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 (0)
Data not yet available
No reference posted for this study.