NCT07255846

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

A Phase 1 Trial of TER-1754 in Patients With Hereditary Hemorrhagic Telangiectasia

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Terremoto Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hereditary Hemorrhagic Telangiectasia (HHT)

Interventions

Type	Name	Description
DRUG	TER-1754	QD or BID, orally in 28-day cycles
DRUG	Placebo	Number of tablets will be confirmed post Phase 1a
DRUG	TER-1754	Phase 1b dose to be determined post Phase 1a

Timeline

• Start date: 2025-12-15
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2025-12-01
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study