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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

Sponsor
ABL Bio, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03292783
Collaborator
National OncoVenture (Other)
45
Enrollment
2
Locations
1
Arm
41.4
Actual Duration (Months)
22.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
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 :
Sep 18, 2017
Actual Primary Completion Date :
Mar 2, 2021
Actual Study Completion Date :
Mar 2, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: NOV150101 (ABL001)

Drug: NOV1501 (ABL001)
VEGF/DLL4 targeting bispecific antibody

Outcome Measures

Primary Outcome Measures

  1. Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) [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

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13620
2 Samsung Medical Center Seoul Korea, Republic of 135-710

Sponsors and Collaborators

  • ABL Bio, Inc.
  • National OncoVenture

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ABL Bio, Inc.
ClinicalTrials.gov Identifier:
NCT03292783
Other Study ID Numbers:
  • NOV150101-101
First Posted:
Sep 26, 2017
Last Update Posted:
Jul 7, 2021
Last Verified:
Jul 1, 2021
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

Study Results

No Results Posted as of Jul 7, 2021