A double-blind, placebo-controlled, randomized, dose-escalating, multicenter, Phase 1 study to assess the safety and tolerability of ART-123 in combination with leucovorin/5-fluorouracil/oxaliplatin and bevacizumab in metastatic colorectal cancer patients

JRCT ID: jRCT2051210165

Registered date:01/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: metastatic colorectal cancer
• Date of first enrollment: 24/03/2022
• Target sample size: 80
• Countries of recruitment: the United States,Japan
• Study type: Interventional

Intervention(s)

Drug: Thrombomodulin alfa (ART-123), IV
Drug: Bevacizumab, IV
Drug: Oxaliplatin, IV
Drug: Levofolinate/ Folinate calcium, IV
Drug: 5-fluorouracil, IV

Outcome(s)

Primary Outcome

Safety endpoints: AEs, Bleeding eventsDLTs, Laboratory tests, Vital signs (body temperature, systolic blood pressure, diastolic blood pressure, heart rate), Anti-ART-123 antibodies and neutralizing antibodies
PK endpoints: Plasma concentration of thrombomodulin, Plasma concentration of 5-FU, Plasma concentration of oxaliplatin, Serum concentration of bevacizumab

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

*18 years of age or older
* Metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum
* ECOG performance status of 0 or 1
* The most recent laboratory findings (including for liver and kidney) within 14 days prior to randomization remain within acceptable ranges Willingness of the patient and the sexual partner to use a highly effective
contraceptive method during the course of the study
* Able to sufficiently understand the clinical study and give written informed consent

Exclude criteria

*History of major hemorrhage
* High risk of hemorrhage
* History of other malignancies
* Active ulcer
* Patients using anti-coagulants and fibrinolytic drugs
* Active Hepatitis B, or known HBs antigen positive
* Prior treatment history with thrombomodulin alfa
* Administration of another investigational medicinal product within 30 days prior to randomization
* Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the Treatment period
* Patients otherwise deemed as inappropriate to participate in the study by the Investigator

Related Information

• Primary Sponsor: Tawara Shunsuke
• Secondary ID(s): NCT05251727