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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03292783
Recruitment Status : Completed
First Posted : September 26, 2017
Last Update Posted : July 7, 2021
Sponsor:
Collaborator:
National OncoVenture
Information provided by (Responsible Party):
ABL Bio, Inc.

Study Description
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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) and recommended phase II dose (RP2D) of NOV1501 (ABL001).

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: NOV1501 (ABL001) Phase 1

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 patients with advanced solid tumors after failure of standard of care.

Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase. DLTs will be assessed as the primary endpoint in this trial.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Dose-escalation and Expansion Phase 1/2a Clinical Trial to Assess the Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and the Anti-tumor Efficacy of NOV1501 (ABL001) in Patients With Advanced Solid Tumors
Actual Study Start Date : September 18, 2017
Actual Primary Completion Date : March 2, 2021
Actual Study Completion Date : March 2, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NOV150101 (ABL001) Drug: NOV1501 (ABL001)
VEGF/DLL4 targeting bispecific antibody


Outcome Measures
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Primary Outcome Measures :
  1. Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) [ Time Frame: From time of 1st administration of ABL001 until day 21. ]
    The maximum tolerated dose/maximum administered dose will be determined by the number of participant experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292783


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of, 13620
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
ABL Bio, Inc.
National OncoVenture
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ABL Bio, Inc.
ClinicalTrials.gov Identifier: NCT03292783    
Other Study ID Numbers: NOV150101-101
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ABL Bio, Inc.:
VEGF
DLL4
Solid Tumors
bispecific antibody
anti-angiogenic