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
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|ClinicalTrials.gov Identifier: NCT03292783|
Recruitment Status : Completed
First Posted : September 26, 2017
Last Update Posted : July 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: NOV1501 (ABL001)||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 18, 2017|
|Actual Primary Completion Date :||March 2, 2021|
|Actual Study Completion Date :||March 2, 2021|
|Experimental: NOV150101 (ABL001)||
Drug: NOV1501 (ABL001)
VEGF/DLL4 targeting bispecific antibody
- Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) [ Time Frame: From time of 1st administration of ABL001 until day 21. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292783
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam-si, Korea, Republic of, 13620|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|