Phase 1Phase 1NCT04014257
A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies
A Phase 1 study testing NOV1601(CHC2014) in people with Phase 1 and Solid Tumor, Adult, run by Handok Inc. at 4 sites in South Korea.
Trial summary
This study is a first-in-human (FIH) study which is required to understand the PK characteristics, MTD, and safety profile of NOV1601(CHC2014) in subjects with solid organ malignancies. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Phase 1, Solid Tumor, Adult
- What is being tested?
- NOV1601(CHC2014)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 9 Aug 2019to 29 Jan 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
- Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease
- At least one evaluable or measurable lesion should be present and identified according to Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1 or Response Assessment in Neuro-Oncology(RANO)
- Relapse after or refractory to systemic drug therapy to malignancy, at least one regimen of cytotoxic chemotherapy, kinase inhibitors including tyrosine kinase inhibitors or immunotherapy which is considered as standard of care if there is no standard regimen recommended, then no experience of systemic drug therapy is acceptable
- Patients with primary central nervous system(CNS) tumors or metastasis, if they have been neurologically stable
- Symptoms should be under control by stable dose of glucocorticoids and analgesic drugs for symptom control at least 2 weeks prior to starting the treatment
- Stable dose of glucocorticoids and analgesic drugs for symptom control should be maintained throughout the study
- Subjects should be off from radiotherapy for at least 14 days prior to the start of study treatment(C1D1) without symptom aggravation
Who cannot join
- Prior high-dose chemotherapy requiring hematopoietic stem cell transplantation
- History or evidence of suspicious leptomeningeal disease
- Previous surgery of gastrectomy, gastrostomy or any medical condition which interferes with oral ingestion of capsule
- Indwelling percutaneous drainage of bile and chest tube
- Evidence of or suspicious symptomatic spinal cord compression, unless appropriately treated and neurologically stable off glucocorticoid for at least 2 weeks
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
National Cancer Center
Goyang-si, Gyeonggi-do
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
About this study
Official title: A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies
This study is a first-in-human (FIH) study which is required to understand the PK characteristics, MTD, and safety profile of NOV1601(CHC2014) in subjects with solid organ malignancies.
Read the detailed description
This is the first-in-human, Phase 1, open-label, multicenter, dose-escalation study to investigate the safety, tolerability, PK, and clinical activity of NOV1601(CHC2014) in subjects with solid organ malignancies. The primary goal of the study is to determine the RP2D of NOV1601(CHC2014) in adult subjects with solid organ malignancies.
Dose escalation will follow a 3+3 design and will be based on prior cohort review. There will be 2 branches of the dosing schedule, once a day(QD) and twice daily(BID).
- Conditions
- Phase 1, Solid Tumor, Adult
- Being tested
- NOV1601(CHC2014)
- Keywords
- tropomyosin receptor kinase, Solid organ malignancies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOV1601(CHC2014)Drug
a highly selective pan-TRK(tropomyosin receptor kinase) inhibitor targeting tropomyosin receptor kinase A (TRKA), tropomyosin receptor kinase B(TRKB), and tropomyosin receptor kinase C(TRKC)
| Study group | Role | What they receive |
|---|---|---|
| NOV1601(CHC2014) | Experimental | a highly selective pan-TRK(tropomyosin receptor kinase) inhibitor targeting tropomyosin receptor kinase A(TRKA), tropomyosin receptor kinase B(TRKB), and tropomyosin receptor kinase C(TRKC) Receives: Drug: NOV1601(CHC2014) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the recommended Phase 2 dose(RP2D) or the maximum tolerated dose(MTD) of NOV1601
MTD will be the RP2D, based on the pharmacokinetic(PK) profiles and safety profiles as assessed by the Safety Monitoring Committee (SMC).
Measured: Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-28).
Secondary outcomes (1)
Number of participants with treatment-related adverse events(TEAE) and serious adverse events(SAE)
Each adverse event will be coded using the Medical Dictionary for Regulatory Activities(version 20.0) classification system. The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Measured: Maximum 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start9 Aug 2019
- Primary completion22 Jan 2021
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase 1Studies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CMG Pharmaceutical Co. Ltd
- Responsible party
- Sponsor
- Investigators
- Dong-Wan Kim, MD, PhD, Principal investigator, Seoul National University HospitalTak Yun, MD, PhD, Principal investigator, National Cancer CenterSang-Joon Shin, MD, PhD, Principal investigator, Severance HospitalYong-Wha Moon, MD, PhD, Principal investigator, CHA Bundang Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014257
- Sponsor's protocol ID
- NOV160101-101
- Status last verified
- Aug 2021
- First submitted
- 2 Jul 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies
- ClinicalTrials.gov ID
- NCT04014257
- Acronym / sponsor ID
- NOV160101-101
- Conditions
- Phase 1, Solid Tumor, Adult
- Keywords
- tropomyosin receptor kinase, Solid organ malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Collaborators
- CMG Pharmaceutical Co. Ltd
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 10 Jul 2019 (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.
This study is a first-in-human (FIH) study which is required to understand the PK characteristics, MTD, and safety profile of NOV1601(CHC2014) in subjects with solid organ malignancies.
Detailed description
This is the first-in-human, Phase 1, open-label, multicenter, dose-escalation study to investigate the safety, tolerability, PK, and clinical activity of NOV1601(CHC2014) in subjects with solid organ malignancies. The primary goal of the study is to determine the RP2D of NOV1601(CHC2014) in adult subjects with solid organ malignancies.
Dose escalation will follow a 3+3 design and will be based on prior cohort review. There will be 2 branches of the dosing schedule, once a day(QD) and twice daily(BID).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOV1601(CHC2014) | Experimental | Drug: NOV1601(CHC2014)a highly selective pan-TRK(tropomyosin receptor kinase) inhibitor targeting tropomyosin receptor kinase A(TRKA), tropomyosin receptor kinase B(TRKB), and tropomyosin receptor kinase C(TRKC) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease
- At least one evaluable or measurable lesion should be present and identified according to Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1 or Response Assessment in Neuro-Oncology(RANO)
- Relapse after or refractory to systemic drug therapy to malignancy, at least one regimen of cytotoxic chemotherapy, kinase inhibitors including tyrosine kinase inhibitors or immunotherapy which is considered as standard of care if there is no standard regimen recommended, then no experience of systemic drug therapy is acceptable
- Patients with primary central nervous system(CNS) tumors or metastasis, if they have been neurologically stable
Key exclusion criteria (5 listed)
- Prior high-dose chemotherapy requiring hematopoietic stem cell transplantation
- History or evidence of suspicious leptomeningeal disease
- Previous surgery of gastrectomy, gastrostomy or any medical condition which interferes with oral ingestion of capsule
- Indwelling percutaneous drainage of bile and chest tube
- Evidence of or suspicious symptomatic spinal cord compression, unless appropriately treated and neurologically stable off glucocorticoid for at least 2 weeks
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 |
|---|---|---|
| NOV1601(CHC2014)a highly selective pan-TRK(tropomyosin receptor kinase) inhibitor targeting tropomyosin receptor kinase A (TRKA), tropomyosin receptor kinase B(TRKB), and tropomyosin receptor kinase C(TRKC) | Drug | NOV1601(CHC2014) |
Primary outcome
the recommended Phase 2 dose(RP2D) or the maximum tolerated dose(MTD) of NOV1601
Time frame: Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-28).
MTD will be the RP2D, based on the pharmacokinetic(PK) profiles and safety profiles as assessed by the Safety Monitoring Committee (SMC).
1 secondary outcome
Number of participants with treatment-related adverse events(TEAE) and serious adverse events(SAE)
Time frame: Maximum 2 years
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 16 Sep 2021.
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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.
Dong-Wan Kim, MD, PhD principal investigator
Seoul National University Hospital
Tak Yun, MD, PhD principal investigator
National Cancer Center
Sang-Joon Shin, MD, PhD principal investigator
Severance Hospital
4 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 NOV1601(CHC2014) in people with Phase 1 and Solid Tumor, Adult, run by Handok Inc. at 4 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 7 inclusion and 5 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
the recommended Phase 2 dose(RP2D) or the maximum tolerated dose(MTD) of NOV1601 (time frame: Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-28).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2021.