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

Overview

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.

Full Title of Study: “A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton’s Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2024

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.

Interventions

  • Drug: TG-1701
    • Oral daily dose
  • Drug: Umbralisib
    • Oral Daily Dose
  • Biological: Ublituximab
    • IV infusion

Arms, Groups and Cohorts

  • Experimental: Arm 1: TG-1701 Monotherapy
    • Participants will receive TG-1701 oral daily dose. As per protocol v6.0, participants from this arm will be transitioned to the long-term extension arm to receive TG-1701 monotherapy.
  • Experimental: Arm 2: TG-1701 + Ublituximab + Umbralisib
    • Participants will receive TG-1701, oral dose in combination with ublituximab, oral dose and umbralisib, fixed IV infusion on specific Days of Cycles 1 and 2, followed by maintenance infusions in Cycles 3 to 6 (Cycle=28 days). As per protocol v6.0, participants from this arm will be transitioned to the long-term extension arm to receive TG-1701 monotherapy.
  • Experimental: Arm 3: Long Term Safety Extension – TG-1701 Monotherapy
    • All the ongoing participants from Arm 1 and 2, will be transitioned to TG-1701 monotherapy in long-term extension period, per protocol version 6.0.

Clinical Trial Outcome Measures

Primary Measures

  • Maximum Tolerated Dose acceptable for participants
    • Time Frame: From first dose up to 30 days post last dose (Up to approximately 4.8 years)
    • To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.

Secondary Measures

  • Overall Response Rate
    • Time Frame: Up to approximately 4.8 years
    • To assess the overall response rate (ORR) in patients with hematologic malignancies

Participating in This Clinical Trial

Inclusion Criteria

  • Relapsed or refractory histologically confirmed B-cell lymphoma or CLL – Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 – Adequate organ function Exclusion Criteria:

  • Prior therapy with a BTK inhibitor (ibrutinib, acalabrutinib, other) – Any major surgery, chemotherapy or immunotherapy within the last 21 days – Known hepatitis B virus, hepatitis C virus or HIV infection

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • TG Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Constantine S. Tam, MD, Study Chair, St. Vincents Hospital

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