NCT05704985

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

Active, enrolled Phase 1 Last updated 23 May 2025

What this trial tests

Phase 1 trial testing DK210 (EGFR) in Cancer in 39 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

3 April 2023

Primary endpoint
1 July 2025

1 October 2025

Quick facts

Lead sponsor	DEKA Biosciences
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	3 April 2023
Primary completion	1 July 2025
Estimated completion	1 October 2025
Sites	7 locations across United States

Drugs / interventions tested

• DK210 (EGFR) — full drug profile →
• Radiation therapy — full drug profile →
• Immune checkpoint blockers — full drug profile →
• Chemotherapy (chemotherapy) — full drug profile →

Conditions studied

• Cancer — all drugs for Cancer →
• Solid Tumor — all drugs for Solid Tumor →
• Colorectal Cancer — all drugs for Colorectal Cancer →
• Pancreas Cancer — all drugs for Pancreas Cancer →

Sponsor

DEKA Biosciences — full company profile →

Who can join

18 and older, any sex, with Cancer or Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of Adverse Events (AEs) with DK210 (EGFR)
  Time frame: Minimum of 90 days from initiation of experimental therapy
  Based on toxicities observed
• Identify recommended dose of DK210 (EGFR)
  Time frame: Initiation of therapy up to day 90
  Based on toxicities observed
• Incidence of Adverse Events (AE) of DK210 (EGFR) in combination with radiation, chemotherapy, or checkpoint blockers in Parts B, C, D
  Time frame: Minimum of 90 days from initiation of experimental therapy
  Based on toxicities observed

Sponsor's own description

This study will evaluate safety, pharmacodynamics and biomarkers of subcutaneous (SC) DK210(EGFR) given as monotherapy and in combination with immunotherapy, chemotherapy or radiation.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Inflammation in cancer: therapeutic opportunities from new insights.
   Xie Y, Liu F, Wu Y, Zhu Y, et al · · 2025 · cited 53× · PMID 39994787 · DOI 10.1186/s12943-025-02243-8
2. Comprehensive Molecular Genetic Analysis in Glioma Patients by Next Generation Sequencing.
   Kim T, Lee A, Ahn S, Park JS, et al · · 2024 · cited 8× · PMID 38317486 · DOI 10.14791/btrt.2023.0036
3. Coupling IL-2 with IL-10 to mitigate toxicity and enhance antitumor immunity.
   Ahn JJ, Dudics S, Langan DP, Smith JD, et al · · 2025 · cited 5× · PMID 40744022 · DOI 10.1016/j.xcrm.2025.102257
4. Next-generation immunotherapy: igniting new hope for lung cancer.
   Li MSC, Chan ALS, Mok KKS, Chan LL, et al · · 2024 · cited 3× · PMID 39649017 · DOI 10.1177/17588359241302021
5. Immune biomarkers for head and neck cancer.
   Sobhani N, D'Angelo A, Kugeratski FG, Nguyen T, et al · · 2025 · cited 1× · PMID 41410866 · DOI 10.1007/s00262-025-04233-7
6. Emerging Immunotherapy and Antibody-Derived Therapeutics for the Treatment of Advanced Non-Small-Cell Lung Cancer: A Review.
   Hou AY, Elantably D, Manochakian R, Velcheti V, et al · · 2026 · PMID 42073614 · DOI 10.3390/cancers18081291
7. Protein engineering to overcome limitations of key cytokines in cancer immunotherapy: current approaches and future perspectives.
   Salazar U, Cioffi P, Taskoparan B, Moraga I, et al · · 2025 · PMID 41081016 · DOI 10.1016/j.iotech.2025.101064