Trials / Active Not Recruiting
Active Not RecruitingNCT05704985
Evaluating Safety and Biomarkers Using DK210 (EGFR) for Locally Advanced or Metastatic EGFR+ Tumors
Dose-finding Phase 1 Trial: Evaluating Safety and Biomarkers Using DK210 (EGFR) for Inoperable Locally Advanced and/or Metastatic EGFR+ Tumors With Progressive Disease Failing Systemic Therapy
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- DEKA Biosciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate safety, pharmacodynamics and biomarkers of subcutaneous (SC) DK210(EGFR) given as monotherapy and in combination with immunotherapy, chemotherapy or radiation.
Detailed description
This study will evaluate DK210(EGFR) as monotherapy and combination in subjects with advanced solid EGFR expressing cancers with documented progressive disease after at least one line of systemic treatment (staging performed by local standard).
Conditions
- Cancer
- Solid Tumor
- Colorectal Cancer
- Pancreas Cancer
- Non Small Cell Lung Cancer
- Head and Neck Cancer
- Gynecologic Cancer
- Skin Cancer
- Kidney Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DK210 (EGFR) | Solution for SC administration |
| RADIATION | Radiation therapy | Short regimen radiation therapy (10 fractions or less) |
| BIOLOGICAL | Immune checkpoint blockers | IV administration of approved PD1 blocker |
| DRUG | Chemotherapy | Single agent or combination of not more than two |
Timeline
- Start date
- 2023-04-03
- Primary completion
- 2025-07-01
- Completion
- 2025-10-01
- First posted
- 2023-01-30
- Last updated
- 2025-05-29
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05704985. Inclusion in this directory is not an endorsement.