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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.

Tracking Information
First Submitted Date  ICMJE September 21, 2017
First Posted Date  ICMJE September 26, 2017
Last Update Posted Date July 7, 2021
Actual Study Start Date  ICMJE September 18, 2017
Actual Primary Completion Date March 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2017)
Dose Limiting Toxicities (DLTs) [ Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-21) ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE Drug: NOV1501 (ABL001)
VEGF/DLL4 targeting bispecific antibody
Study Arms  ICMJE Experimental: NOV150101 (ABL001)
Intervention: Drug: NOV1501 (ABL001)
Publications * Yeom DH, Lee YS, Ryu I, Lee S, Sung B, Lee HB, Kim D, Ahn JH, Ha E, Choi YS, Lee SH, You WK. ABL001, a Bispecific Antibody Targeting VEGF and DLL4, with Chemotherapy, Synergistically Inhibits Tumor Progression in Xenograft Models. Int J Mol Sci. 2020 Dec 29;22(1). pii: E241. doi: 10.3390/ijms22010241.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 4, 2021)
45
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2017)
39
Actual Study Completion Date  ICMJE March 2, 2021
Actual Primary Completion Date March 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03292783
Other Study ID Numbers  ICMJE NOV150101-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party ABL Bio, Inc.
Original Responsible Party National OncoVenture
Current Study Sponsor  ICMJE ABL Bio, Inc.
Original Study Sponsor  ICMJE National OncoVenture
Collaborators  ICMJE National OncoVenture
Investigators  ICMJE Not Provided
PRS Account ABL Bio, Inc.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP