Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies

ID
Name
TG-1701-101
Description
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.
Trial arms
Trial start
2018-09-10
Estimated PCD
2024-06-01
Trial end
2024-06-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
TG-1701
Oral daily dose
Arms:
Arm 1: TG-1701 Monotherapy, Arm 2: TG-1701 + Ublituximab + Umbralisib, Arm 3: Long Term Safety Extension - TG-1701 Monotherapy
Umbralisib
Oral Daily Dose
Arms:
Arm 2: TG-1701 + Ublituximab + Umbralisib
Other names:
TGR-1202
Ublituximab
IV infusion
Arms:
Arm 2: TG-1701 + Ublituximab + Umbralisib
Other names:
TG-1101
Size
172
Primary endpoint
Maximum Tolerated Dose acceptable for participants
From first dose up to 30 days post last dose (Up to approximately 4.8 years)
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 172, 'type': 'ACTUAL'}}
Updated at
2024-04-16

1 organization

3 products

2 indications

Organization
TG Therapeutics
Product
TG-1701
Indication
Non-Hodgkin Lymphoma
Indication
Chronic Lymphocytic Leukemia
Product
Umbralisib
Product
Ublituximab