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

April 15, 2024 updated by: TG Therapeutics, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • TG Therapeutics Investigational Trial Site
    • Victoria
      • East Melbourne, Victoria, Australia
        • TG Therapeutics Investigational Trial Site
      • Fitzroy, Victoria, Australia
        • TG Therapeutics Investigational Trial Site
    • Western Australia
      • Nedlands, Western Australia, Australia
        • TG Therapeutics Investigational Trial Site
  • Poland
      • Kraków, Poland, 30-510
        • TG Therapeutics Investigational Trial Site
      • Lublin, Poland, 20-090
        • TG Therapeutics Investigational Trial Site
      • Warszawa, Poland, 02-781
        • TG Therapeutics Investigational Trial Site
      • Wrocław, Poland, 50-367
        • TG Therapeutics Investigational Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: TG-1701
Oral daily dose
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.
Drug: TG-1701
Oral daily dose
Drug: Umbralisib
Oral Daily Dose
Other Names:
  • TGR-1202
Biological: Ublituximab
IV infusion
Other Names:
  • TG-1101
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.
Drug: TG-1701
Oral daily dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From first dose up to 30 days post last dose (Up to approximately 4.8 years)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TG Therapeutics, Inc.

Investigators

  • Study Chair: Constantine S. Tam, MD, St. Vincents Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2018

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (Actual)

September 14, 2018

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG-1701-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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