Advanced Solid TumorsPhase 1NCT03292783
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
A Phase 1 study testing NOV1501 (ABL001) in people with Advanced Solid Tumors, run by ABL Bio, Inc. at 2 sites in South Korea.
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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- NOV1501 (ABL001)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 18 Sep 2017to 2 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Bundang Hospital
Seongnam-si, 13620
Samsung Medical Center
Seoul, 135-710
About this study
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
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).
Read the 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- NOV1501 (ABL001)
- Keywords
- VEGF, DLL4, Solid Tumors, bispecific antibody, anti-angiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOV1501 (ABL001)Drug
VEGF/DLL4 targeting bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| NOV150101 (ABL001) | Experimental | Not described Receives: Drug: NOV1501 (ABL001) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From time of 1st administration of ABL001 until day 21.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start18 Sep 2017
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- ABL Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National OncoVenture
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292783
- Sponsor's protocol ID
- NOV150101-101
- Status last verified
- Jul 2021
- First submitted
- 21 Sep 2017
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33383646
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03292783
- Acronym / sponsor ID
- NOV150101-101
- Conditions
- Advanced Solid Tumors
- Keywords
- VEGF, DLL4, Solid Tumors, bispecific antibody, anti-angiogenic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- ABL Bio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National OncoVenture
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOV150101 (ABL001) | Experimental | Drug: NOV1501 (ABL001) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOV1501 (ABL001)VEGF/DLL4 targeting bispecific antibody | Drug | NOV150101 (ABL001) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Derived from this study: PubMed 33383646Yeom 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.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NOV1501 (ABL001) in people with Advanced Solid Tumors, run by ABL Bio, Inc. at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03292783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.