Study of DNP002 in Patients With 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.
| Condition(s) | Advanced Solid Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 19 Years |
| Sex | All |
| Lead sponsor | Kumho HT Inc. |
| Locations | Goyang-si, Gyeonggi-do, South Korea |
| Start date | 2021-05-24 |
| NCT ID | NCT06466265 |
| Official listing | https://clinicaltrials.gov/study/NCT06466265 |