Status:
COMPLETED
This is a Study to Evaluate the Safety and Tolerability of the Study Drug ABL001, and to Determine the Maximum Tolerated Dose and/or Recommended Phase 2 Study Dose of ABL001
Lead Sponsor:
ABL Bio, Inc.
Collaborating Sponsors:
National OncoVenture
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
The purpose of this open-label, dose escalation-dose expansion, Phase 1 clinical trial is to evaluate the safety, pharmacokinetics and anti-tumor activity and determine the maximum tolerated dose (MTD...
Detailed Description
This is an open-label, Phase 1 dose escalation and expansion study of NOV1501 (ABL001) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and the anti-tumor efficacy of ABL001 in...
Eligibility Criteria
Inclusion
- ≥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
- History of hypersensitivity reactions to any of the components of the investigational product or other drugs of the same class
- Less than 4 weeks have elapsed since a major surgery and 2 weeks have elapsed since a minor surgery
- New York Heart Association (NYHA) class ≥II congestive heart failure (CHF)
- Persistent, clinically significant NCI-CTCAE v4.03 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
- Peritoneal and/or pleural fluid drainage within 28 days prior to screening
- History of hemoptysis within 28 days prior to screening
- Serious, untreated scar, active ulcer, or untreated fracture
Key Trial Info
Start Date :
September 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03292783
Start Date
September 18 2017
End Date
March 2 2021
Last Update
July 7 2021
Active Locations (2)
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1
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
2
Samsung Medical Center
Seoul, South Korea, 135-710