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Active, not recruiting Phase 1

Evaluating Safety and Biomarkers Using DK210 (EGFR) for Locally Advanced or Metastatic EGFR+ Tumors

NCT05704985 · tracked via the Priya Life Science USA tracker
Sponsor
DEKA Biosciences
Phase
Phase 1
Started
2023-04-03
Last updated
2025-05-29

Condition(s) studied

CancerSolid TumorColorectal CancerPancreas CancerNon Small Cell Lung CancerHead and Neck CancerGynecologic CancerSkin CancerKidney Cancer

Investigational drug(s) / intervention(s)

DK210 (EGFR) →Radiation therapyImmune checkpoint blockers →Chemotherapy

DK210 (EGFR): Solution for SC administration

Radiation therapy: Short regimen radiation therapy (10 fractions or less)

Immune checkpoint blockers: IV administration of approved PD1 blocker

Chemotherapy: Single agent or combination of not more than two

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * ECOG performance status of 0-1 * Life expectancy of \>3 months according to the investigator's judgment * Solid tumors known for response on Il-2 or Il-10 and/or high expression of EGFR like all Non-small cell Lung, Skin, Head and Neck, Colon, Kidney, Bladder, Pancreatic cancers and all squamous cell carcinoma of other organs can be included with a classical histology report, specific EGFR expression or amplification reports are needed for other solid tumor types like gynecologic, prostate or triple negative breast cancer * Measurable disease, defined as at least one (non-irradiated) lesion measurable on CT/MRI or bone scan as defined by RECIST 1.1. * Progressive disease (PD) at study entry defined as one or more of the following criteria: * Clinical PD with performance decline, clinical symptoms and/or observed tumor growth * PD documented with imaging showing at least 20% growth (largest diameter) and/or new lesions * Adequate cardiovascular, hematological, liver, and renal function. * Subjects have failed one or more lines of systemic therapy and have not been operated on or receiving anti-cancer medication for at least 4 weeks. * Males and females of childbearing potential must agree to use effective contraception starting prior to the first day of treatment and continuing during treatment * Additional criteria may apply Exclusion Criteria: * Subjects with documented diffuse peritoneal disease or persistent abundant ascites * Subjects with known prolonged QtC interval * Concomitant or recent (\<4 weeks or 5 half-lives of the last treatment, whichever is shorter) treatment with agents with anti-tumor activity, including immunotherapies, or experimental therapies. Bone treatments and supportive care can be continued * Major surgery within 4 weeks, Radiation therapy for the treatment of metastases within less than 3 weeks (if single fraction of radiotherapy, then within 2 weeks) and radionuclide therapy for the treatment of metastases within 4 weeks prior to screening * Uncontrolled intercurrent illness including, but not limited to, ongoing and uncontrolled infection (TBC, COVID or HIV patients treated with at least two anti-retroviral drugs and control of their infection with at least 500 /mm3 CD4+ T-cells in their blood and patients cured from Hepatitis B or C (i.e negativity of PCR) and liver function compatible with eligibility criteria are allowed to participate), multiple myeloma, multiple sclerosis, myasthenia gravis, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirement * Any other conditions that, in the investigator's opinion, might indicate the subject to be unsuitable for the study * Additional criteria may apply

Primary outcome measure(s)

  • Incidence of Adverse Events (AEs) with DK210 (EGFR) — Minimum of 90 days from initiation of experimental therapy
    Based on toxicities observed
  • Identify recommended dose of DK210 (EGFR) — 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 — Minimum of 90 days from initiation of experimental therapy
    Based on toxicities observed

Trial sites (7)

FacilityCityRegionStatus
City of Hope Duarte California
Northwell Health Manhasset New York
OU Health Stephenson Cancer Center Oklahoma City Oklahoma
Mary Crowley Cancer Research Dallas Texas
University of Texas Southwestern Dallas Texas
The University of Texas M.D. Anderson Cancer Center Houston Texas
NEXT Oncology Fairfax Virginia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05704985 on ClinicalTrials.gov ↗ ← All trials in the USA