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

NCT03292783 | Completed Phase 1

• 1 other identifier: NOV150101-101
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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).

Conditions

Advanced Solid Tumors

Keywords

VEGF; DLL4; Solid Tumors; bispecific antibody; anti-angiogenic

Outcome Measures

Primary Outcomes (1)

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

  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.

  From time of 1st administration of ABL001 until day 21.

Study Arms (1)

NOV150101 (ABL001)

EXPERIMENTAL

Drug: NOV1501 (ABL001)

Interventions

NOV1501 (ABL001) DRUG

VEGF/DLL4 targeting bispecific antibody

NOV150101 (ABL001)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• ABL Bio, Inc.: lead
• National OncoVenture: collaborator

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33383646 DERIVED

MeSH Terms

Interventions

asciminib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 26, 2017
• Study Start: September 18, 2017
• Primary Completion: March 2, 2021
• Study Completion: March 2, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

KR (2)