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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Cancer; Cancer; Head and Neck Cancer; Gynecologic Cancer; Colorectal Cancer; Solid Tumor; Non Small Cell Lung Cancer; Skin Cancer; Pancreas Cancer
• Intervention / Treatment: Biological: DK210 (EGFR); Drug: Chemotherapy; Radiation: Radiation therapy; Biological: Immune checkpoint blockers

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).

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope
  • New York
    • Manhasset, New York, United States, 11030
      • Northwell Health
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • OU Health Stephenson Cancer Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
    • Dallas, Texas, United States, 75230
      • Mary Crowley Cancer Research
    • Houston, Texas, United States, 77030
      • The University of Texas M.D. Anderson Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Next Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DK210 (EGFR) Monotherapy (Dose escalation and expansion); DK210 (EGFR) will be administered as monotherapy three times per week via subcutaneous (SC) administration. Dose will be escalated from 0.025 mg/kg to 0.3 mg/kg or until unacceptable toxicity, disease progression, or withdrawal of consent. An expansion cohort at the optimal dose will be enrolled in parallel with the combination arms.	Biological: DK210 (EGFR); Solution for SC administration
Experimental: DK210 (EGFR) + chemotherapy; In patients with good tolerance of first line systemic therapy, DK210 (EGFR) will be administered three times per week via subcutaneous (SC) administration in combination with second-line intravenous (IV) chemotherapy until unacceptable toxicity, disease progression, or withdrawal of consent	Biological: DK210 (EGFR); Solution for SC administration; Drug: Chemotherapy; Single agent or combination of not more than two; Other Names: Capecitabine; Carboplatin; Oxaliplatin; Fluorouracil; Paclitaxel
Experimental: DK210 (EGFR) + radiation; In patients with need of palliative radiation, DK210 (EGFR) will be administered three times per week via subcutaneous (SC) administration in combination with short course radiation therapy (10 fractions or less) until unacceptable toxicity, disease progression, or withdrawal of consent	Biological: DK210 (EGFR); Solution for SC administration; Radiation: Radiation therapy; Short regimen radiation therapy (10 fractions or less)
Experimental: DK210 (EGFR) + immunotherapy; In patients with good tolerance of first line immunotherapy, DK210 (EGFR) will be administered three times per week via subcutaneous (SC) administration in combination with intravenous (IV) immune checkpoint blockers until unacceptable toxicity, disease progression, or withdrawal of consent	Biological: DK210 (EGFR); Solution for SC administration; Biological: Immune checkpoint blockers; IV administration of approved PD1 blocker; Other Names: Pembrolizumab; Nivolumab

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR)	Overall response rate (ORR) will be based on clinical examination and investigator review of radiographic images	Initiation of therapy up to approximately 12 months
Best response rate at 9 weeks	Based on investigator clinical examination and review of radiographic images	Initiation of therapy through Day 63
Progression-free (PFS)	Time from first dose of DK210 (EGFR) to first documentation of clinical or radiographic disease progression or death due to any cause, whichever occurs first.	Study Day 1 until the date of first documented progression or date of death from any cause, assessed up to approximately 24 months
Overall Survival (OS)	Time from first dose of DK210 (EGFR) to the time of death	Assessed up to 24 months
Serum concentrations of DK210 (EGFR) will be determined at various time points	Concentration vs time and standard pharmacokinetic (PK) parameters will be summarized by dose level	From initiation of treatment through 12 months (every 9 weeks)
Serum will be assayed for the presence of anti-DK210 (EGFR) antibodies	Results will be summarized by dose level	From initiation of treatment through 12 months (every 9 weeks)
Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points	Results will be summarized by dose level	From initiation of treatment through day 63
Serum concentrations of proinflammatory cytokines such as IL-6, IL-10, TNFa, IL-1b, and interferon (IFN)-g will be assessed at various time points	Results will be summarized by dose level	From initiation of treatment through 12 months (every 9 weeks)

Collaborators and Investigators

• Sponsor: DEKA Biosciences
• Investigators: Study Director: Medical Officer, DEKA Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Immunotherapy; Oncology; Cytokine; IL-2; Immuno-oncology; Interleukin 2; DEKA; IL-10; Interleukin 10; DK210(EGFR); DEKA Biosciences
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Urologic Neoplasms; Pancreatic Neoplasms; Kidney Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Capecitabine; Oxaliplatin; Nivolumab; Immune Checkpoint Inhibitors; Fluorouracil; Carboplatin; Pembrolizumab; Paclitaxel
• Other Study ID Numbers: DEKA-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At this time, IPD sharing has not been defined and/or decided if it will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No