A Trial of TER-1754 in Patients With Hereditary Hemorrhagic Telangiectasia

Last updated: January 6, 2026
Sponsor: Terremoto Biosciences Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Anemia

Abnormal Blood Vessels (Arteriovenous Malformations)

Treatment

TER-1754

Placebo

Clinical Study ID

NCT07255846
TER-1754-C01
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Able to provide a signed and dated written informed consent prior to anystudy-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 2units of RBCs within the preceding 24 weeks.

  • Adequate bone marrow function

  • Adequate renal function

  • Adequate hepatic function

Exclusion

Exclusion Criteria:

  • Prior nonresponse or loss of response to an agent that inhibits AKT1 and/or AKT2 asthe 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

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: TER-1754
Phase: 1
Study Start date:
December 15, 2025
Estimated Completion Date:
March 31, 2028

Study Description

This is a first-in-human, Phase 1, multicenter trial that includes two parts:

  • Phase 1a (dose escalation) will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of TER-1754 in patients with HHT and determine the maximum tolerated or administered dose.

  • Phase 1b (proof of concept) will evaluate clinical activity and further characterize the safety profile of TER-1754 in patients with HHT. The Phase 1b treatment period is separated into a blinded treatment segment followed by an open-label extension (OLE) segment.

Connect with a study center

  • Innovative Hematology, Inc.

    Indianapolis 4259418, Indiana 4921868 46260
    United States

    Active - Recruiting

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