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

Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03671590
Collaborator
(none)
200
Enrollment
8
Locations
2
Arms
56.7
Anticipated Duration (Months)
25
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
Actual Study Start Date :
Sep 10, 2018
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

TG-1701 oral daily dose

Drug: TG-1701
Oral daily dose
Experimental: Arm 2

TG-1701 + Ublituximab + Umbralisib

Drug: TG-1701
Oral daily dose

Drug: Umbralisib
Oral Daily Dose
Other Names:
  • TGR-1202

    • Biological: Ublituximab
    Ublituximab at a fixed IV infusion on specific Days of Cycles 1 and 2, followed by maintenance infusions in Cycles 3 to 6 (Cycle=28 days)
    Other Names:
  • TG-1101

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose acceptable for participants [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 Outcome Measures

    1. Overall Response Rate [Up to approximately 4.8 years]

      To assess the overall response rate (ORR) in patients with hematologic malignancies

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 TG Therapeutics Investigational Trial Site East Melbourne Victoria Australia
    2 TG Therapeutics Investigational Trial Site Fitzroy Victoria Australia
    3 TG Therapeutics Investigational Trial Site Nedlands Western Australia Australia
    4 TG Therapeutics Investigational Trial Site Adelaide Australia
    5 TG Therapeutics Investigational Trial Site Kraków Poland 30-510
    6 TG Therapeutics Investigational Trial Site Lublin Poland 20-090
    7 TG Therapeutics Investigational Trial Site Warszawa Poland 02-781
    8 TG Therapeutics Investigational Trial Site Wrocław Poland 50-367

    Sponsors and Collaborators

    • TG Therapeutics, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TG Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT03671590
    Other Study ID Numbers:
    • TG-1701-101
    First Posted:
    Sep 14, 2018
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Aug 12, 2022