A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients
Reason given: Change of Development Plan
Key facts
- Where
- Seongnam-si and Seoul, South KoreaSee the 4 sites
- Phase
- Phase 1/2
Where in South Korea
- Seoul National University Bundang HospitalSeongnam-si, South KoreaNo longer taking part
- Asan Medical CenterSeoul, South KoreaNo longer taking part
- Samsung Medical CenterSeoul, South KoreaNo longer taking part
- Seoul National University HospitalSeoul, South KoreaNo longer taking part
Trial details
- Who runs it
- Handok Inc.
- Trial code
- NCT04492033
- Record updated
- 27 January 2025
- Original description
This study is a Phase 1b/2 multi-center study to assess the safety, tolerability, pharmacokinetics of CTX-009 (ABL001) in combination with Irinotecan or Paclitaxel in patients with advanced or metastatic solid tumors.Read full original descriptionShow less
A Phase 1b/2a Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Patients With Advanced or Metastatic Solid Tumors
This study is a Phase 1b/2 multi-center study to assess the safety, tolerability, pharmacokinetics of CTX-009 (ABL001) in combination with Irinotecan or Paclitaxel in patients with advanced or metastatic solid tumors.
Inclusion: P1b only: Patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors; P2 only: Patients with histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, ampullary carcinoma); P2 only: Patients who have shown disease progress or recurrence of disease after receiving first-line or second-line systemic chemotherapy, including treatment with gemcitabine in combination with a platinum agent; Patients aged 19 years or older; At least one lesion measurable defined by response evaluation criteria in solid tumors (RECIST) version 1.1; Life expectancy ≥ 12 weeks; ECOG performance status 0 or 1; Women of childbearing potential must have a negative pregnancy test outcome; Patients must provide written informed consent to voluntary participation in this study.
Exclusion: History of hypersensitivity reactions to any of the components of the investigational product or other drugs of the same class (humanized/human monoclonal antibody) and irinotecan or paclitaxel; Less than 4 weeks have elapsed since a surgery; Persistent, clinically significant NCI-CTCAE v5.0 Grade ≥ 2 toxicities from the previous anticancer therapy; Participation in another clinical trial within 30 days prior to initiation of study treatment and received an investigational drug treatment; Administration of antiplatelets or anticoagulants within 2 weeks prior to screening; Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids; History of cardiac illness: New York Heart Association (NYHA) class ≥ II congestive heart failure (CHF), uncontrolled hypertension, hypertension crisis, pulmonary hypertension, myocardial infarction, uncontrolled arrhythmia, unstable angina; Severe infections or major and unhealed injury (active ulcer, untreated fracture); HIV or other severe diseases that warrant the exclusion from this study; Symptomatic or uncontrolled central nervous system (CNS) metastasis; Pregnant or lactating women or patients planning to become pregnant during the study.