A Phase 1 interventional study of TER-1754 and Placebo in Hereditary Hemorrhagic Telangiectasia (HHT), sponsored by Terremoto Biosciences Inc.. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Terremoto Biosciences Inc. · Phase 1, Interventional, and Treatment
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.
This is a first-in-human, Phase 1, multicenter trial that includes two parts:
106 studies on the registry are indexed under Telangiectasia, Hereditary Hemorrhagic; 24 are open to participants now.
Browse Telangiectasia, Hereditary Hemorrhagic studies →Terremoto Biosciences Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TER-1754 Oral tablets
Drug: TER-1754
Placebo oral tablets
Drug: Placebo
Patient will receive one of the two doses determined post Phase 1a
Drug: TER-1754
Patient will receive one of the two doses determined post Phase 1a
Drug: TER-1754
QD or BID, orally in 28-day cycles
Number of tablets will be confirmed post Phase 1a
Phase 1b dose to be determined post Phase 1a
Phase 1a: Safety and Tolerability of TER-1754
Incidence of adverse events characterized by type, seriousness, relationship to study treatment, and severity according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: up to 48 weeks
Phase 1a: Maximum Tolerated Dose (MTD) and/or Maximum Administrated Dose (MAD) of TER-1754
Incidence dose-limiting toxicities (DLTs) characterized by type, seriousness, and severity according to NCI CTCAE v5.0 (dose escalation only).
Time frame: 28 days
Phase 1b - Evaluate the Change from baseline in epistaxis and symptom-related clinical activity scores at Week 24
Assess change from baseline in epistaxis duration
Time frame: 48 weeks
Phase 1a and 1b: Evaluate TER-1754 Peak Plasma Concentration (Cmax)
Cmax of TER-1754 following single and multiple dosing.
Time frame: up to 48 weeks
Phase 1a and 1b: Evaluate change from baseline in Daily Epistaxis (EQ) Questionnaire
Change from baseline in EQ Questionnaire based on patient self-reported epistaxis frequency, severity and duration, where: Epistaxis frequency: number of epistaxis events per week Epistaxis duration: total minutes of bleeding Epistaxis intensity - From mild to severe: Spotting, dripping, dripping quickly, steady stream, pouring, and gushing.
Time frame: up to 48 weeks
Phase 1a and 1b: Evaluate HHT-specfic quality of life
Change from baseline in HHT-specific QoL (HHT-QoL), where The total score ranges from 0 (no limitations) to 16 (severe limitations).
Time frame: Up to 48 weeks
Phase 1a and 1b: Evaluate TER-1754 Time to Peak Concentration (Tmax)
Time at which maximum observed plasma concentration occurs.
Time frame: Up to 48 weeks
Phase 1a and 1b: Evaluate TER-1754 Area Under the Concentration-Time Curve (AUC0-last)
Area under the plasma concentration-time curve from time zero to last measurable concentration (AUC0-last)
Time frame: Up to 48 weeks
Phase 1a and 1b: Evaluate TER-1754 AUC0-24
Area under the plasma concentration-time curve from time zero to 24 hours (AUC0-24)
Time frame: Up to 48 weeks
Phase 1a and 1b: Evaluate TER-1754 AUC∞
Area under the plasma concentration versus time curve extrapolated to infinity (AUC∞) of TER-1754 following single and multiple dosing.
Time frame: Up to 48 weeks
Phase 1a and 1b: Evaluate TER-1754 Terminal Half-Life (t½)
Terminal elimination half-life (t½) of TER-1754 calculated from the terminal slope of the plasma concentration versus time profile.
Time frame: Up to 48 weeks
Phase 1a and 1b: Evaluate TER-1754 Mean Residence Time (MRT)
Mean residence time (MRT) of TER-1754.
Time frame: Up to 48 weeks
Phase 1a and 1b: Evaluate TER-1754 Accumulation Ratio at Steady State
Accumulation ratio of TER-1754 at steady state, calculated as the ratio of exposure at steady state to exposure after the first dose.
Time frame: Up to 48 weeks
Phase 1a and 1b: Change from baseline in Nasal Obstruction Symptom Evaluation Score for HHT (NOSE HHT)
Change from baseline in the NOSE HHT score, a validated scale measuring nasal obstruction in HHT. The score ranges from 0 to 4, with higher scores indicating more severe symptoms.
Time frame: up to 48 weeks
Plan to share: No
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This study is withdrawn, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Telangiectasia, Hereditary Hemorrhagic →
Terremoto Biosciences Inc.