Trial | NCT03671590  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    172
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.
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 Started
Sep 10
2018
Primary Completion
Jun 30
2024
Anticipated
Study Completion
Jun 30
2024
Anticipated
Last Update
Dec 21
2023

Drug TG-1701

Oral daily dose

Drug Umbralisib

Oral Daily Dose

  • Other names: TGR-1202

Biological Ublituximab

IV infusion

  • Other names: TG-1101

Arm 1: TG-1701 Monotherapy Experimental

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.

Arm 2: TG-1701 + Ublituximab + Umbralisib Experimental

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.

Arm 3: Long Term Safety Extension - TG-1701 Monotherapy Experimental

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.

Criteria 

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
No Results Posted