Clinical trial · Interventional
TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas
A One Year, Randomized, Double-Blind, Placebo-Controlled Study of TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas
NCT04335357CI-TRIAL-00044489unknownPhase 2ClinicalTrials.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)
This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, efficacy, PK, and PD of the chimeric dopamine-somatostatin receptor agonist, TBR-760, in adult patients with NFPA over 52 weeks.
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 |
|---|---|---|---|
| Non-Functional Pituitary Adenoma | — | UNRESOLVED | — |
| Pituitary Tumor, Nonfunctioning | Pituitary Gland Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| TBR-760 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- The appearance and fill of placebo syringes will be identical to the active comparator.
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- TBR-760
- description
- TBR-760 is supplied as a ready-to-use solution in pre-filled syringes at a concentration of 5 mg/ml.
- interventionNames
- Drug: TBR-760
Primary outcomes (1)
- measure
- tumor volume reduction
- timeFrame
- 52 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Key Inclusion Criteria: * Confirmed diagnosis of NFPA (defined as lack of clinical and biochemical evidence of adenohypophyseal hormone excess), and be status-post one TSS with a NFPA remnant of ≥ 10mm (maximum diameter) * Study subjects must be capable of giving informed consent and reading and signing the informed consent form after the nature of the study has been fully explained by the Investigator or Investigator designee * Study subject must be willing and able to complete all study assessments and procedures and to communicate effectively with the Investigator and site staff. Key Exclusion Criteria: * Has undergone more than one TSS, or had TSS \<6 months prior to screening, or is anticipated to require TSS within 6 months of Screening * Has undergone radiation therapy to the head for any reason, or is already planned to have or anticipated to require radiation therapy during the study period; * Has any contraindications to magnetic resonance imaging including allergy or intolerance to gadolinium or gadolinium-based contrast; * In the opinion of the Investigator, the patient is unable to meet the requirements of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.