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

Conditions

Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma

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.

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.

Chan Y. Cheah, Wojciech Jurczak, Masa Lasica, Tomasz Wróbel, Stanley Cheung et al. (14 authors)

Blood2021-11-055 citations

10.1182/blood-2021-145911

TG‐1701, A SELECTIVE BRUTON TYROSINE KINASE (BTK) INHIBITOR, AS MONOTHERAPY AND IN COMBINATION WITH UBLITUXIMAB AND UMBRALISIB (U2) IN PATIENTS WITH B‐CELL MALIGNANCIES

Chan Y. Cheah, Wojciech Jurczak, Masa Lasica, Nicholas Wickham, Tomasz Wróbel et al. (17 authors)

Hematological Oncology2021-06-01

10.1002/hon.148_2880

Updated results of the selective Bruton tyrosine kinase (BTK) inhibitor TG-1701, as monotherapy and in combination with ublituximab and umbralisib (U2) in patients (pts) with B-cell malignancies.

Chan Y. Cheah, Wojciech Jurczak, Masa Lasica, Nicholas Wickham, Tomasz Wróbel et al. (17 authors)

Journal of Clinical Oncology2021-05-201 citations

10.1200/jco.2021.39.15_suppl.7525

Phase 1 Study of TG-1701, a Selective Irreversible Inhibitor of Bruton's Tyrosine Kinase (BTK), in Patients with Relapsed/Refractory B-Cell Malignancies

Chan Y. Cheah, Nicholas Wickham, Costas K. Yannakou, Katharine L. Lewis, Chi‐Hung Hui et al. (12 authors)

Blood2019-11-136 citations

10.1182/blood-2019-126951

Interventions

DRUGTG-1701

Oral daily dose

DRUGUmbralisib

Oral Daily Dose

BIOLOGICALUblituximab

IV infusion

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Australia, Poland

Outcome results

None listed