Clinical trial · Interventional
A Study of OMP-336B11 in Subjects With Locally Advanced or Metastatic Tumors
A Phase 1a Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of OMP-336B11 Administered as a Single Agent to Subjects With Locally Advanced or Metastatic Solid Tumors
NCT03295942CI-TRIAL-00046551terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
The purpose of this study is to test the safety and efficacy of OMP-336B11. OMP-336B11 is an engineered human protein that was designed to bind to the GITR receptor on T cells and activate the immune system to recognize and eliminate cancer cells.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OMP-336B11 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OMP-336B11
- description
- Intravenous (in the vein) infusions of OMP-336B11
- interventionNames
- Drug: OMP-336B11
Primary outcomes (1)
- measure
- The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-336B11
- timeFrame
- Subjects will be assessed for DLTs through the end of the first cycle (Days 1-29)
- description
- Incidence of dose limiting toxicities (DLTs)
Secondary outcomes (6)
- measure
- Pharmacokinetic Outcome Measures (CL)
- timeFrame
- Screening through 12 weeks post treatment termination
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced or metastatic solid tumors that have exhausted standard of care therapy * Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1 * Age \>21 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ and marrow function * For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit. * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Receiving any other investigational agents or any other anti-cancer therapy * Active autoimmune disease or a history of severe autoimmune disease or syndrome * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * Pregnancy, lactating or breastfeeding women * History of primary CNS malignancy, or leptomeningeal disease or CNS metastases * Significant uncontrolled intercurrent illness that will limit the patient's ability to participate in the study * Inability to comply with study and follow up procedures
References
Publications (0)
Data not yet available
No reference posted for this study.