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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
TG Therapeutics Investigational Trial Site
East Melbourne, Victoria, Australia
TG Therapeutics Investigational Trial Site
Fitzroy, Victoria, Australia
TG Therapeutics Investigational Trial Site
Nedlands, Western Australia, Australia
TG Therapeutics Investigational Trial Site
Maximum Tolerated Dose acceptable for participants
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
Time frame: From first dose up to 30 days post last dose (Up to approximately 4.8 years)
Overall Response Rate
To assess the overall response rate (ORR) in patients with hematologic malignancies
Time frame: Up to approximately 4.8 years
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Adelaide, Australia
TG Therapeutics Investigational Trial Site
Krakow, Poland
TG Therapeutics Investigational Trial Site
Lublin, Poland
TG Therapeutics Investigational Trial Site
Warsaw, Poland
TG Therapeutics Investigational Trial Site
Wroclaw, Poland