RecruitingPhase 1NCT07255846
A Trial of TER-1754 in Patients With Hereditary Hemorrhagic Telangiectasia
A Phase 1 Trial of TER-1754 in Patients With Hereditary Hemorrhagic Telangiectasia
Sponsor
Terremoto Biosciences Inc.
Enrollment
90 participants
Start Date
Dec 15, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria8
- 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
Exclusion Criteria4
- Prior nonresponse or loss of response to an agent that inhibits AKT1 and/or AKT2 as the primary mechanism of action.
- Diagnosis of DM requiring insulin treatment
- Known significant bleeding sources other than nasal, GI, or menstrual/ uterine
- Known underlying hypoproliferative anemia or clinically significant hemolytic anemia
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Interventions
DRUGTER-1754
QD or BID, orally in 28-day cycles
DRUGPlacebo
Number of tablets will be confirmed post Phase 1a
DRUGTER-1754
Phase 1b dose to be determined post Phase 1a
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07255846