Name: Tovecimig (CTX-009) in Second-line advanced biliary tract cancer: Special populations
Published: 2026-09-21T22:15:09-04:00

Product information and disease description Product description Product information

Special populations

4 evidence topics · 4 sources

Eligibility restrictions applied in COMPANION-002

Criterion	Quoted record
Minimum age	“18 Years”
Performance status	“Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1”
Life expectancy	“Predicted life expectancy of at least 12 weeks”
Hematologic function	“Hemoglobin ≥ 9.0 g/dL”
Hepatic function	“Total bilirubin ≤ 1.5 X ULN”
Renal function	“Estimated creatinine clearance ≥ 30 mL/min based on Cockcroft-Gault”
Proteinuria	“Urine protein ≤ 1+ by Dipstick”
Biliary drainage	“Patients with percutaneous transhepatic biliary drains (PTBD)”
Cardiovascular disease	“Uncontrolled arrhythmia”
Pulmonary hypertension	“Pulmonary hypertension”
Central nervous system metastases	“Symptomatic or uncontrolled central nervous system (CNS) metastasis”
Hemorrhage	“Active hemorrhage, hemorrhagic diathesis, coagulopathy or tumor in great arteries”
Pulmonary disease	“Interstitial lung disease or pulmonary fibrosis”
Paclitaxel tolerance	“Patients with contraindications to paclitaxel therapy”
Electrocardiogram	“QT interval (Fridericia's formula) (QTcF) interval > 450msec at the time of screening”
Pregnancy and lactation	“Pregnant or lactating patients, or patients planning to become pregnant during the clinical study”
Hypersensitivity	“History of hypersensitivity reactions to any components of the investigational product or other drugs of the same class (humanized/human monoclonal antibody drugs) or paclitaxel”

Contraception requirements

“Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile), or be at least 2 years postmenopausal, or commit to use two acceptable forms of birth control (defined as the use of an IUD, a barrier method with spermicide, condoms, or any form of hormonal contraceptives) or abstinence for the duration of the study and for 6 months following the last dose of study treatment. Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 6 months following the last dose of study treatment” (opens the source at this quote in a new tab)

Age, sex, and race of participants randomized in COMPANION-002

Characteristic	Tovecimig plus paclitaxel (n=111)	Paclitaxel (n=57)
Median age, years	“65.0”	“63.0”
Male, n (%)	“53 (47.7)”	“24 (42.1)”
Female, n (%)	“58 (52.3)”	“33 (57.9)”
Asian, n (%)	“17 (15.3)”	“10 (17.5)”
White, n (%)	“84 (75.7)”	“40 (70.2)”
African American, n (%)	“4 (3.6)”	“6 (10.5)”
Unknown or other, n (%)	“6 (5.4)”	“1 (1.8)”

Age and organ-function eligibility in the phase 1 study

“Adult patients (aged ≥19 years) with confirmed of any progressive locally advanced or metastatic solid tumors that had relapsed or were refractory to the standard therapy were enrolled.” (opens the source at this quote in a new tab)
“Patients who had clinically significant cardiovascular disease, including pulmonary hypertension and myocardial infarction, hypersensitivity to humanized/human mAb, or who previously received anti‐DLL4 antibody were excluded.” (opens the source at this quote in a new tab)

Pediatric use, pregnancy and lactation, and dedicated renal or hepatic impairment pharmacokinetic studies

No evidence found.