Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Trebananib/kg · 1 trial · 1 indication
DLT is defined as any treatment-related, grade 4 or higher hematologic or grade 3 or higher non-hematologic toxicity (according to the Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0; hematologic toxicity means any toxicities which are categorized in blood/bone marrow category of CTCAE), except for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and infusion reaction, occurred during the first 28 days after the initial administration (before examination on Study Day 29). DLT also includes AST or ALT: \>10\*upper limit of normal (ULN) international units per liter (IU/L).
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Treatment emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.
Change relative to baseline in electrocardiogram measured throughout study. Significant change in ECG observed at any time point was summarized and reported.
Vital signs included body temperature, diastolic and systolic blood pressure, and pulse (beats per minutes). clinically significant change in vital signs observed at any time point was summarized and reported.
The number of participants with any abnormal standard safety laboratory values collected throughout study. Parameters assessed were hematology, chemistry, coagulation and urinalysis. Abnormal laboratory values observed at any time point was summarized and reported.
Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve.
Cmax is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve.
Tmax is the time to reach the maximum serum concentration (Cmax), equal to time (hours) to Cmax.
Tmax is the time to reach the maximum serum concentration (Cmax), equal to time (hours) to Cmax.
AUC (0-tau) is the area under the serum concentration-time curve during a dosing interval, where tau is the length of the dosing interval (168 hours for once weekly regimen).
AUC (0-tau) is the area under the serum concentration-time curve during a dosing interval, where tau is the length of the dosing interval (168 hours for once weekly regimen).
Cmin was the observed serum concentration at 168 hours postdose.
Cmin was the observed serum concentration at 168 hours postdose.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state, estimated as: Vss = MRTinf \*CLss, where MRTinf is mean residence time of drug extrapolated to infinity and CLss is the systemic clearance at the steady state. Vss was normalized to participant's body weight.
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.
CL is a quantitative measure of the rate at which a drug substance is removed from the body. Systemic clearance at steady state (CLss) was calculated as the ratio of dose administered to AUC (0 - tau), where AUC (0 - tau) is the area under the serum concentration-time curve during a dosing interval, where tau is the length of the dosing interval (168 hours for once weekly regimen). CLss was normalized to participant's body weight.
Accumulation ratio (AR) was calculated by dividing the individual AUC (0-tau) value at Week 4 by the corresponding individual AUC (0-tau) value at Week 1.
| Arm | Type | Description |
|---|---|---|
| Trebananib 3 mg/kg | EXPERIMENTAL | Trebananib (AMG 386) 3 milligram/kilogram (mg/kg), 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks). |
| Trebananib 10 mg/kg | EXPERIMENTAL | Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks). |
| Trebananib 30 mg/kg | EXPERIMENTAL | Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks). |
| Name | Type | Description |
|---|---|---|
| Trebananib 3 mg/kg | DRUG | Trebananib (AMG 386) 3 mg/kg, intravenous infusion. |
| Trebananib 10 mg/kg | DRUG | Trebananib (AMG 386) 10 mg/kg, intravenous infusion. |
| Trebananib 30 mg/kg | DRUG | Trebananib (AMG 386) 30 mg/kg, intravenous infusion. |
Inclusion Criteria: 1. Histologically or cytologically documented and definitively diagnosed, advanced solid tumor that is refractory to standard treatment or for which no curative therapy is available. 2. Has Eastern Cooperative Oncology Group (ECOG) of 0 or 1 (within 2 weeks prior to enrollment). ...
Trebananib 3 mg/kg is an investigational therapy studied in adults with advanced solid tumors, including neoplasms. It was evaluated in a Phase 1 trial of Japanese participants with advanced solid tumors. It is not an approved treatment and remains in clinical development for oncology indications.
Trebananib 3 mg/kg targets ANGPT1 and ANGPT2, also known as angiopoietin-1 and angiopoietin-2. It acts as an inhibitor of these angiopoietin proteins, which are involved in blood vessel formation. By binding ANGPT1 and ANGPT2, the small molecule is designed to interfere with angiogenesis in tumors.
Trebananib 3 mg/kg is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor associated with the clinical development of this asset. The compound is also referenced by the identifier CHEMBL2108568 in chemical databases.
Trebananib 3 mg/kg is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 1 program has been completed, with no active trials currently listed for this asset.
Trebananib 3 mg/kg was studied in one completed Phase 1 trial, NCT02525536. That study evaluated the safety, tolerability, and pharmacokinetics of trebananib (AMG 386) in adult Japanese participants with advanced solid tumors. It enrolled 18 participants, used a controlled design, and was not randomized or double blinded.
Yes, Trebananib 3 mg/kg is an alternative name for trebananib. The 3 mg/kg designation refers to a dose level of the same investigational compound, which is also known as AMG 386. Both names refer to the same small molecule inhibitor studied in advanced solid tumors.