A Phase 1 Trial of TER-1754 in Patients With Hereditary Hemorrhagic Telangiectasia
Status: Withdrawn
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a Phase 1a/1b, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of TER-1754 (a novel AKT1 inhibitor) in patients with HHT.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
• A clinical diagnosis of HHT as defined by the Curaçao criteria
• Baseline (1-month) ESS ≥ 4
• ECOG ≤ 2
• Anemia or parental iron infusion of at least 500 mg or transfusion of at least 2 units of RBCs within the preceding 24 weeks.
• Adequate bone marrow function
• Adequate renal function
• Adequate hepatic function
Locations
United States
Indiana
Innovative Hematology, Inc.
Indianapolis
Time Frame
Start Date: 2025-12-15
Completion Date: 2028-03
Treatments
Experimental: Phase 1a (Dose Escalation) TER-1754 dose escalation
TER-1754 Oral tablets
Placebo_comparator: Phase 1b (Proof of Concept)
Placebo oral tablets
Experimental: Phase 1b (Proof of Concept) - Phase 1b TER-1754 lower dose to begin post determination in Phase 1a
Patient will receive one of the two doses determined post Phase 1a
Experimental: Phase 1b (Proof of Concept) - Phase 1b TER-1754 higher dose to begin post determination in Phase 1a.
Patient will receive one of the two doses determined post Phase 1a
Related Therapeutic Areas
Sponsors
Leads: Terremoto Biosciences Inc.