TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas

Tiburio Therapeutics

Status and phase: Unknown; Phase 2

Conditions: Non-Functional Pituitary Adenoma; Pituitary Tumor, Nonfunctioning

Treatments: Drug: Placebo; Drug: TBR-760

Study type: Interventional

Funder types: Industry

Identifiers

NCT04335357

TBR-760-NFPA-201

Details and patient eligibility

About

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.

Full description

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. Approximately 150 patients will be enrolled.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

The appearance and fill of placebo syringes will be identical to the active comparator.

Treatment:

Drug: Placebo

TBR-760

Active Comparator group

Description:

TBR-760 is supplied as a ready-to-use solution in pre-filled syringes at a concentration of 5 mg/ml.

Treatment:

Drug: TBR-760