Study of DNP002 in Patients With Solid Tumors

NCT ID: NCT06466265

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-24
• Study Completion Date: 2025-06-30

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participant Group/Arm

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.

Group Type: EXPERIMENTAL

DNP002

Intervention Type: DRUG

Anti-CEACAM6 monoclonal antibody

Interventions

DNP002

Anti-CEACAM6 monoclonal antibody

Intervention Type: DRUG

Other Intervention Names

H2319

Eligibility Criteria

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.

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.

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kumho HT Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moonki Choi, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center

Locations

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Moonki Choi, M.D., Ph.D.

Role: CONTACT

choi.moonki@ncc.re.kr

82-31-920-1737

Facility Contacts

Moonki Choi, M.D., Ph.D.

Role: primary

choi.moonki@ncc.re.kr

82-31-920-1737

Other Identifiers

NCC2021-0034

Identifier Type: -

Identifier Source: org_study_id