Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TRU-016 · 1 trial · 1 indication
Response was assessed by the investigator on the basis of clinical, radiological, and pathological (i.e., bone marrow) criteria, using the IWG criteria (Cheson et al 2007). A CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
| Arm | Type | Description |
|---|---|---|
| TRU-016+bendamustine+rituximab | EXPERIMENTAL | Two dose levels (10 and 20 mg/kg) of TRU 016 combined with rituximab 375 mg/m2 and bendamustine 90 mg/m2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles. |
| Name | Type | Description |
|---|---|---|
| TRU-016 | DRUG | 100 mg TRU-016 lyophilized solution for infusion at 10 or 20 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle |
| Bendamustine | DRUG | Bendamustine by IV administration on Days 1 and 2 of each 28 day cycle. |
| Rituximab | DRUG | Rituximab by IV administration at 375 mg/m\^2 on Day 2 of each 28 day cycle. |
Inclusion Criteria 1. Age 18 years or older 2. Histologically confirmed diagnosis of indolent non-Hodgkin's B-cell lymphoma (ie, follicular lymphoma, small lymphocytic lymphoma, and marginal zone lymphoma) that has relapsed (relapsed is defined as confirmed progressive disease (PD) after receiving ...
TRU-016 is an investigational small molecule being studied for Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL), and recurrent B-cell Small Lymphocytic Lymphoma. It has been evaluated in patients with previously treated CLL and in combination with other therapies for relapsed disease.
TRU-016 is being developed by Aptevo Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol APVO. The company has sponsored clinical trials of TRU-016 in hematologic malignancies.
TRU-016 is in Phase 1 clinical development. All three clinical trials listed for TRU-016 are Phase 1 studies, and they have all been completed. TRU-016 is investigational and has not been approved by the FDA.
TRU-016 has been studied in three completed Phase 1 trials: NCT00614042 in previously treated CLL or NHL, NCT01188681 in relapsed CLL comparing TRU-016 plus bendamustine versus bendamustine alone, and NCT01317901 in relapsed indolent lymphoma combining TRU-016 with rituximab and bendamustine.
TRU-016 is the primary name used in clinical trials and does not have alternative names listed in the available data. It is an investigational small molecule being studied for hematologic cancers.