Overview
The purpose of this open-label, combination dose escalation, Phase 1b/2a clinical trial is to evaluate the safety, pharmacokinetics and anti-tumor activity and determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of combination therapy with ABL001(NOV1501) and Paclitaxel/Irinotecan .
Eligibility
Inclusion Criteria:
- 19 year old patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors
- Lesions measured by tumor markers or by CT/MRI must be evaluable based on response evaluation criteria in solid tumors (RECIST) version 1.1.
- Life expectancy 12 weeks
- ECOG performance status 2
- Women of childbearing potential must have a negative pregnancy test outcome
- Patients must provide written informed consent to voluntary participation in this study.
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 major surgery and 2 weeks have elapsed since a minor 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 severe traumatic systemic disorders
- 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 screening
- 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