Advanced Solid TumorPhase 1NCT06466265
Study of DNP002 in Patients With Solid Tumors
A Phase 1 study testing DNP002 in people with Advanced Solid Tumor, run by Kumho HT Inc. at 1 site in South Korea.
Trial summary
This is an open-label, Phase 1, first-in-human, dose-escalation study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of the anti-Carcinoembryonic-antigen-related-cell-adhesion-molecule-6 (CEACAM6) antibody DNP002 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- DNP002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 May 2021to Jun 2025
- 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
- Male or female patients aged 19 years or older as of the date of written informed consent.
- Patients with histologically or cytologically confirmed unresectable locally advanced and/or metastatic solid tumors who have been refractory to or had disease progression after standard treatment and have no other available standard treatment options.
- Patients with at least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Patients with an expected survival of greater than or equal to 12 weeks.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Patients confirmed to have adequate hematologic, renal, and hepatic function.
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- Patients who have recovered to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 or baseline status from reversible side effects of prior anticancer therapies (excluding alopecia [regardless of grade] or grade 2 peripheral neuropathy or any laboratory test, blood pressure, and ECG results that meet the inclusion/exclusion criteria).
- For women of childbearing potential, negative pregnancy test (urine-hCG and/or serum hCG) at the time of clinical trial participation.
- For women of childbearing potential and men, no plans for pregnancy from screening to 24 weeks after treatment cessation and willingness to use appropriate contraception methods.
- Voluntary written informed consent for clinical trial participation.
Who cannot join
- 1. At the screening visit, you have any of the following comorbidities:
- Hematologic malignancies, including lymphoma.
- Interstitial lung disease or pulmonary fibrosis.
- Bowel obstruction or bowel perforation.
- Clinically significant pleural effusion, ascites, or pleural effusion.
- Severe infections or other uncontrolled active infectious diseases requiring treatment with antibiotics, antiviral drugs, etc. that may affect safety and efficacy evaluation during the clinical trial period, as determined by the investigator.
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- Uncontrolled hypertension (systolic blood pressure (SBP) /diastolic blood pressure (DBP) ≥ 160/100 mmHg).
- QTc interval exceeding 480 msec (same criteria for both sexes) using Fridericia's QT correction formula.
- Active hepatitis B or C (hepatitis C virus antibody (HCV Ab) positive but HCV ribonucleic acid (RNA) negative may be considered as previous infection and eligible for clinical trial).
- Clinically significant symptoms or uncontrolled central nervous system (CNS) metastases or carcinomatous meningitis (clinical trial eligibility is possible if no progression has been confirmed clinically and on computed tomography (CT)/magnetic resonance imaging (MRI) for at least 4 weeks prior to the administration of investigational drugs after treatment for CNS or brain metastases and no treatment with steroids or other medications is required at least 2 weeks before administration of investigational drugs).
- 2. At the screening visit, individuals with the following medical history (including surgical/intervention history):
- Major surgery or clinically significant traumatic injury within 4 weeks prior to screening
- Significant cardiovascular disease such as unstable angina, myocardial infarction, congestive heart failure, stroke, or unstable arrhythmia within 24 weeks prior to screening
- Immunosuppressive disease (e.g., acquired immune deficiency syndrome (AIDS), human immunodeficiency virus (HIV), etc.) or autoimmune disease
- Psychiatric disorder that, in the opinion of the investigator, significantly affects the clinical trial
- 3. Subjects who have received the following drug therapies (pharmacological/non-pharmacological):
- History of immunosuppressive medication within 2 weeks prior to baseline (Day 1 administration date) (Note: Topical, ophthalmic, intra-articular, intranasal, inhaled corticosteroids, and systemic corticosteroids with prednisolone equivalent to 10 mg/day or less are considered exceptions)
- Other anticancer therapy (excluding investigational medicinal products and immune checkpoint inhibitors) within 3 weeks prior to baseline (Day 1 administration date) (Note: Point radiation for the purpose of relieving symptoms such as bone pain, bronchial obstruction, and skin lesions is allowed, but participation is not allowed if the subject has a history of nitrosoureas or mitomycin-C within 6 weeks prior to baseline)
- Radiation (chemo)therapy, chemotherapy, targeted agents (small molecule drugs, monoclonal antibodies), hormonal therapy, etc.
- History of immune checkpoint inhibitor administration within 4 weeks prior to baseline (Day 1 administration date) (e.g., anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-PD-L2, anti-cluster of differentiation (CD) 137, anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4), etc.)
- History of anti-carcinoembryonic antigen-related cell adhesion molecule (CEACAM) 6 medication within 4 weeks prior to baseline (Day 1 administration date)
- 4. Subjects with severe hypersensitivity or other immune-related adverse events to monoclonal antibody preparations or the active substance or excipients of DNP002
- 5. Subjects who participated in other clinical trials and received investigational products (or medical devices) within 4 weeks prior to baseline
- 6. Other subjects who are deemed ineligible for this clinical trial by the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Moonki Choi, M.D., Ph.D., 82-31-920-1737, choi.moonki@ncc.re.kr
About this study
Official title: An Open-label, Dose-finding, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of DNP002 in Patients With Advanced Solid Tumors
This is an open-label, Phase 1, first-in-human, dose-escalation study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of the anti-Carcinoembryonic-antigen-related-cell-adhesion-molecule-6 (CEACAM6) antibody DNP002 in patients with advanced solid tumors.
Read the detailed description
The primary objectives of this study are to evaluate the safety and tolerability of DNP002 in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). The secondary objectives are to evaluate the pharmacokinetic properties and preliminary anti-tumor effects in patients with solid tumors. The exploratory objectives are to analyze the expression and relationship with efficacy of various tumor and blood biomarkers.
- Conditions
- Advanced Solid Tumor
- Being tested
- DNP002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNP002Drug
Also called H2319
Anti-CEACAM6 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Participant Group/Arm | Experimental | Experimental: Patients with advanced solid tumors
Dose escalation with patients having solid tumors. Patients receive escalating doses of DNP002 intravenously for 1 hour on Day 1 of each 14-day cycle (Q2W) or each 21-day cycle (Q3W).
This course will be repeated in the absence of disease progression or unacceptable toxicity. Receives: Drug: DNP002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
DLT is assessed according to NCI-CTCAE v5.0. The assessment is conducted only in the 2-week interval for subjects receiving the first dose (2-week interval subject) or the 3-week interval for subjects receiving the first dose (3-week interval subject).
Measured: Up to 2 or 3 weeks
Incidence and severity of treatment emergent adverse events
Describe the character and incidence of toxicity based on CTCAE v5.0 that occur receiving DNP002.
Measured: Up to 2 years
Characterize the area under the concentration-time curve (AUC) of the pharmacokinetics (PK) of DNP002
Samples for pharmacokinetic evaluation will be collected immediately prior to each of the 5 doses, and at predetermined time intervals after the 1st and 5th doses.
Measured: Day 1 (pre-dose), 1 hour (post-dose), 2, 4, 8 10, 12 hours, Day 2, Day 3, Day 8 after 1st or 5th doses of the investigational drug.
Characterize peak plasma concentration (Cmax) of the pharmacokinetics (PK) of DNP002
Samples for pharmacokinetic evaluation will be collected immediately prior to each of the 5 doses, and at predetermined time intervals after the 1st and 5th doses.
Measured: Day 1 (pre-dose), 1 hour (post-dose), 2, 4, 8 10, 12 hours, Day 2, Day 3, Day 8 after 1st or 5th doses of the investigational drug.
Secondary outcomes (4)
Overall response rate (ORR)
Percentage of patients whose best response to DNP002 is either a Complete response or Partial response, both defined according to RECIST or iRECIST criteria respectively.
Measured: Up to 2 years
Leukocyte immune phenotyping
Whole blood flow cytometry analysis for characterization of blood leukocyte/lymphocyte including MDSC with regards to subpopulation and activation before and under treatment in all patients.
Measured: Day 1 (pre-dose), before the first, third, and fifth doses of the investigational drug, as well as 24 hours after the first and fifth doses.
Serum biomarkers
Total concentration of Arginase-1, soluble CEACAM6, CEA, Interferon-gamma and Interleukin-6 in serum derived from whole blood taken before and under treatment in all patients.
Measured: Day 1 (pre-dose), before the first, third, and fifth doses of the investigational drug, as well as 4 hours after the first and fifth doses.
Concentration of anti-drug antibodies
Concentration in plasma
Measured: Prior to administration at each dose (The investigational drug should be continued with dosing every two weeks as long as there is no disease progression or unacceptable toxicity.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start24 May 2021
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kumho HT Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moonki Choi, M.D., Ph.D., Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466265
- Sponsor's protocol ID
- NCC2021-0034
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-finding, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of DNP002 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06466265
- Acronym / sponsor ID
- NCC2021-0034
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kumho HT Inc.Industry (pharma, biotech, devices)
- Study start
- 24 May 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 20 Jun 2024 (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 is an open-label, Phase 1, first-in-human, dose-escalation study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of the anti-Carcinoembryonic-antigen-related-cell-adhesion-molecule-6 (CEACAM6) antibody DNP002 in patients with advanced solid tumors.
Detailed description
The primary objectives of this study are to evaluate the safety and tolerability of DNP002 in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). The secondary objectives are to evaluate the pharmacokinetic properties and preliminary anti-tumor effects in patients with solid tumors. The exploratory objectives are to analyze the expression and relationship with efficacy of various tumor and blood biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant Group/Arm | Experimental | Drug: DNP002Experimental: Patients with advanced solid tumors Dose escalation with patients having solid tumors. Patients receive escalating doses of DNP002 intravenously for 1 hour on Day 1 of each 14-day cycle (Q2W) or each 21-day cycle (Q3W). This course will be repeated in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients aged 19 years or older as of the date of written informed consent.
- Patients with histologically or cytologically confirmed unresectable locally advanced and/or metastatic solid tumors who have been refractory to or had disease progression after standard treatment and have no other available standard treatment options.
- Patients with at least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Patients with an expected survival of greater than or equal to 12 weeks.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
Key exclusion criteria (24 listed)
- Hematologic malignancies, including lymphoma.
- Interstitial lung disease or pulmonary fibrosis.
- Bowel obstruction or bowel perforation.
- Clinically significant pleural effusion, ascites, or pleural effusion.
- Severe infections or other uncontrolled active infectious diseases requiring treatment with antibiotics, antiviral drugs, etc. that may affect safety and efficacy evaluation during the clinical trial period, as determined by the investigator.
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 |
|---|---|---|
| DNP002Also: H2319Anti-CEACAM6 monoclonal antibody | Drug | Participant Group/Arm |
Primary outcome
Dose-limiting toxicity
Time frame: Up to 2 or 3 weeks
DLT is assessed according to NCI-CTCAE v5.0. The assessment is conducted only in the 2-week interval for subjects receiving the first dose (2-week interval subject) or the 3-week interval for subjects receiving the first dose (3-week interval subject).
Incidence and severity of treatment emergent adverse events
Time frame: Up to 2 years
Describe the character and incidence of toxicity based on CTCAE v5.0 that occur receiving DNP002.
Characterize the area under the concentration-time curve (AUC) of the pharmacokinetics (PK) of DNP002
Time frame: Day 1 (pre-dose), 1 hour (post-dose), 2, 4, 8 10, 12 hours, Day 2, Day 3, Day 8 after 1st or 5th doses of the investigational drug.
Samples for pharmacokinetic evaluation will be collected immediately prior to each of the 5 doses, and at predetermined time intervals after the 1st and 5th doses.
Characterize peak plasma concentration (Cmax) of the pharmacokinetics (PK) of DNP002
Time frame: Day 1 (pre-dose), 1 hour (post-dose), 2, 4, 8 10, 12 hours, Day 2, Day 3, Day 8 after 1st or 5th doses of the investigational drug.
Samples for pharmacokinetic evaluation will be collected immediately prior to each of the 5 doses, and at predetermined time intervals after the 1st and 5th doses.
4 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 2 years
Leukocyte immune phenotyping
Time frame: Day 1 (pre-dose), before the first, third, and fifth doses of the investigational drug, as well as 24 hours after the first and fifth doses.
Serum biomarkers
Time frame: Day 1 (pre-dose), before the first, third, and fifth doses of the investigational drug, as well as 4 hours after the first and fifth doses.
Concentration of anti-drug antibodies
Time frame: Prior to administration at each dose (The investigational drug should be continued with dosing every two weeks as long as there is no disease progression or unacceptable toxicity.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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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.
Moonki Choi, M.D., Ph.D. principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DNP002 in people with Advanced Solid Tumor, run by Kumho HT Inc. at 1 site 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 10 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moonki Choi, M.D., Ph.D. (82-31-920-1737, choi.moonki@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (time frame: Up to 2 or 3 weeks). The study lists 4 primary outcomes in all. 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 20 Jun 2024.