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

NCT ID: NCT03292783

Last Updated: 2021-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-18
• Study Completion Date: 2021-03-02

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NOV150101 (ABL001)

Group Type: EXPERIMENTAL

NOV1501 (ABL001)

Intervention Type: DRUG

VEGF/DLL4 targeting bispecific antibody

Interventions

NOV1501 (ABL001)

VEGF/DLL4 targeting bispecific antibody

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National OncoVenture

OTHER

Sponsor Role: collaborator

ABL Bio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

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):241. doi: 10.3390/ijms22010241.

Reference Type: DERIVED

PMID: 33383646 (View on PubMed)

Other Identifiers

NOV150101-101

Identifier Type: -

Identifier Source: org_study_id