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

ABL001-P1bC

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.

2020-06-22

2023-11-22

2025-07-31

Active (not recruiting)

Early phase I

92

Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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 * 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 * Persistent, clinically significant NCI-CTCAE v5.0 Grade ≥ 2 toxicities from the previous anticancer therapy * Severe infections or major and unhealed injury (active ulcer, untreated fracture) * Symptomatic or uncontrolled central nervous system (CNS) metastasis * Pregnant or lactating women or patients planning to become pregnant during the study * 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 * HIV or other severe diseases that warrant the exclusion from this study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 92, 'type': 'ESTIMATED'}}

2023-12-28