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Tovecimig (CTX-009)

Second-line advanced biliary tract cancer

Also known as ABL001
Last updated
89 sources

Product information and disease descriptionProduct descriptionProduct informationPharmacology

Pharmacokinetics

5 evidence topics · 1 source

Population pharmacokinetic model in patients with solid tumors

“A total of 712 plasma concentrations from 30 patients with relapsed or refractory solid tumors were collected from a phase 1 study” (opens the source at this quote in a new tab)

“The PK of ABL001/CTX‐009 was well described by a two‐compartment model with a parallel first‐order and Michaelis–Menten elimination kinetics. Body weight was selected as a significant covariate on V1.” (opens the source at this quote in a new tab)

Model parameter estimates
ParameterEstimate (relative standard error, %)
Clearance, L/h“0.0184 (18)”
Central volume of distribution, L“3.87 (5)”
Intercompartmental clearance, L/h“0.0207 (16)”
Peripheral volume of distribution, L“1.31 (28)”
Elimination half-life and time to steady state

“The model‐derived elimination half‐life was approximately 5.7 days, indicating that plasma ABL001/CTX‐009 concentrations would reach a steady‐state in patients with solid tumor in about 4–6 weeks.” (opens the source at this quote in a new tab)

Simulated exposure: fixed dosing compared with weight-based dosing and alternative intervals

“Simulations after administrations of fixed or weight‐based doses showed similar plasma concentrations. Additionally, 10 mg/kg for every other week and 15 mg/kg for every three‐week administration showed comparable plasma concentrations.” (opens the source at this quote in a new tab)

“When comparing the optimal dosing strategy, the ABL001/CTX‐009 plasma concentrations administered every 2 weeks of 10 mg/kg and every 3 weeks of 15 mg/kg showed similar average plasma concentrations” (opens the source at this quote in a new tab)

Simulated regimenMaximal plasma concentration, mg/LAverage plasma concentration at steady state, mg/L
Fixed dose, 700 mg“263.1 ± 68.5”“123.9 ± 65.2”
Weight-based dose, 10 mg/kg“232.3 ± 68.8”“111.3 ± 66.0”
15 mg/kg every 3 weeks“296.1 ± 77.4”“107.6 ± 68.5”
Bioanalytical method

“Plasma concentrations of ABL001/CTX‐009 were analyzed using a dual antigen‐binding enzyme‐linked immunosorbent assay (ELISA, SpectraMax 190, Molecular Devices). The plasma samples were placed in the ELISA plate coated with recombinant human DLL4, and after the binding process, a horseradish peroxidase‐conjugated human anti‐VEGF A antibody was used to detect the analyte.” (opens the source at this quote in a new tab)

Immunogenicity and pharmacokinetics in organ impairment

No evidence found.