Clinical trial NCT03292783: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: VEGF
DLL4
Solid Tumors
bispecific antibody
anti-angiogenic
Lead sponsor: ABL Bio, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National OncoVenture
First posted: 2017-09-26
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
timeFrame: From time of 1st administration of ABL001 until day 21.
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: 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.