Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06466265
Other study ID # NCC2021-0034
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 24, 2021
Est. completion date June 2025

Study information

Verified date June 2024
Source Kumho HT Inc.
Contact Moonki Choi, M.D., Ph.D.
Phone 82-31-920-1737
Email choi.moonki@ncc.re.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date June 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Male or female patients aged 19 years or older as of the date of written informed consent. 2. 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. 3. Patients with at least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 4. Patients with an expected survival of greater than or equal to 12 weeks. 5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status = 1. 6. Patients confirmed to have adequate hematologic, renal, and hepatic function. 7. 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). 8. For women of childbearing potential, negative pregnancy test (urine-hCG and/or serum hCG) at the time of clinical trial participation. 9. 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. 10. Voluntary written informed consent for clinical trial participation. Exclusion Criteria: 1. At the screening visit, you have any of the following comorbidities: 1. Hematologic malignancies, including lymphoma. 2. Interstitial lung disease or pulmonary fibrosis. 3. Bowel obstruction or bowel perforation. 4. Clinically significant pleural effusion, ascites, or pleural effusion. 5. 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. 6. Uncontrolled hypertension (systolic blood pressure (SBP) /diastolic blood pressure (DBP) = 160/100 mmHg). 7. QTc interval exceeding 480 msec (same criteria for both sexes) using Fridericia's QT correction formula. 8. 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). 9. 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): 1. Major surgery or clinically significant traumatic injury within 4 weeks prior to screening 2. Significant cardiovascular disease such as unstable angina, myocardial infarction, congestive heart failure, stroke, or unstable arrhythmia within 24 weeks prior to screening 3. Immunosuppressive disease (e.g., acquired immune deficiency syndrome (AIDS), human immunodeficiency virus (HIV), etc.) or autoimmune disease 4. 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): 1. 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) 2. 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. 3. 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.) 4. 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
DNP002
Anti-CEACAM6 monoclonal antibody

Locations

Country Name City State
Korea, Republic of National Cancer Center Goyang-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Kumho HT Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Up to 2 or 3 weeks
Primary Incidence and severity of treatment emergent adverse events Describe the character and incidence of toxicity based on CTCAE v5.0 that occur receiving DNP002. Up to 2 years
Primary 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. 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.
Primary 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. 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 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. Up to 2 years
Secondary 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. 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.
Secondary 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. 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.
Secondary Concentration of anti-drug antibodies Concentration in plasma 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.)
See also
  Status Clinical Trial Phase
Recruiting NCT06223308 - A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Completed NCT05508100 - Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors Phase 1
Not yet recruiting NCT05515185 - B7-H3 Targeting CAR-T Cells Therapy for B7-H3 Positive Solid Tumors Early Phase 1
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT02836600 - A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors Phase 1
Recruiting NCT04890613 - Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation Phase 1
Recruiting NCT04390737 - Evaluate the Safety and Clinical Activity of HH2853 Phase 1/Phase 2
Recruiting NCT05981703 - A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT06007482 - A Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1
Completed NCT04108676 - Effect of Omeprazole on PK of Fluzoparib in Healthy Male Subjects Phase 1
Recruiting NCT05798611 - Study of ART0380 in Patients With Biologically Selected Solid Tumors Phase 2
Recruiting NCT05076396 - PM14 Administered Intravenously to Patients With Advanced Solid Tumors Phase 1
Recruiting NCT06054932 - Safety, Tolerability, and Immunogenicity of LK101 Alone in Participants With Incurable Solid Tumors Phase 1
Recruiting NCT06008366 - A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04825392 - A Phase Ib Study of HX008 in Patients With Advanced Solid Tumors Phase 1
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Not yet recruiting NCT06365918 - Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis Phase 1
Recruiting NCT05461287 - Safety, Tolerability and Pharmacokinetics Study of QLS31904 in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT05569057 - A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma Phase 1
Recruiting NCT05443126 - A Study of EP0031 in Patients With Advanced RET-altered Malignancies Phase 1/Phase 2