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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: NOV1501 (ABL001)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NOV150101 (ABL001)<br> | Drug: NOV1501 (ABL001)<br>* VEGF/DLL4 targeting bispecific antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VEGF, DLL4, Solid Tumors, bispecific antibody, anti-angiogenic