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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292783
• Other study ID #: NOV150101-101
• Status: Completed
• Phase: Phase 1
• Start date: September 18, 2017
• Est. completion date: March 2, 2021

Study information

• Verified date: July 2021
• Source: ABL Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2, 2021
• Est. primary completion date: March 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
ABL Bio, Inc.	National OncoVenture

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.