NCT03671590

Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies

A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: TG Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 trial to evaluate the safety, pharmacokinetics and efficacy of TG-1701, a Bruton's Tyrosine Kinase (BTK) inhibitor in patients with relapsed or refractory B-cell malignancies.

Detailed description

This Phase I clinical trial aims to evaluate the safety of the investigational drug TG-1701 both as a single-agent and in combination with other investigational drugs, specifically ublituximab and umbralisib. As per protocol v6.0, combination therapy (TG-1701 + Ublituximab + Umbralisib) will be discontinued and the participants from Arm 1 and 2 will be transitioned to the long-term extension period to receive TG-1701 monotherapy.

Conditions

• Non Hodgkin Lymphoma
• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	TG-1701	Oral daily dose
DRUG	Umbralisib	Oral Daily Dose
BIOLOGICAL	Ublituximab	IV infusion

Timeline

• Start date: 2018-09-10
• Primary completion: 2024-05-21
• Completion: 2024-05-21
• First posted: 2018-09-14
• Last updated: 2024-07-19

Locations

8 sites across 2 countries: Australia, Poland

Regulatory

• FDA-regulated drug study