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

Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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, followed by maintenance infusions
    Other Names:
  • TG-1101
  • Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose acceptable for participants [28 days (1 cycle of therapy)]

      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 1 year]

      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

    SiteCityStateCountryPostal Code
    1TG Therapeutics Investigational Trial SiteEast MelbourneVictoriaAustralia
    2TG Therapeutics Investigational Trial SiteFitzroyVictoriaAustralia
    3TG Therapeutics Investigational Trial SiteNedlandsWestern AustraliaAustralia
    4TG Therapeutics Investigational Trial SiteAdelaideAustralia
    5TG Therapeutics Investigational Trial SiteKrakówPoland30-510
    6TG Therapeutics Investigational Trial SiteLublinPoland20-090
    7TG Therapeutics Investigational Trial SiteWarszawaPoland02-781
    8TG Therapeutics Investigational Trial SiteWrocławPoland50-367

    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:
    Nov 12, 2021
    Last Verified:
    Nov 1, 2021
    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:

    Study Results

    No Results Posted as of Nov 12, 2021