Clinical trial · Interventional
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
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
NCT03292783CI-TRIAL-00052559completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NOV1501 (ABL001) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NOV150101 (ABL001)
- interventionNames
- Drug: NOV1501 (ABL001)
Primary outcomes (1)
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDYeom 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