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

NCT05704985 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: DEKA-1
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Cancer; Solid Tumor; Colorectal Cancer; Pancreas Cancer; Non Small Cell Lung Cancer; Head and Neck Cancer; Gynecologic Cancer; Skin Cancer; Kidney Cancer

Keywords

Cytokine; IL-2; Interleukin 2; IL-10; Interleukin 10; Oncology; Immuno-oncology; DK210(EGFR); Immunotherapy; DEKA; DEKA Biosciences

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Overall response rate (ORR)

  Initiation of therapy up to approximately 12 months

• Best response rate at 9 weeks

  Initiation of therapy through Day 63

• Progression-free (PFS)

  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)

  Assessed up to 24 months

• Serum concentrations of DK210 (EGFR) will be determined at various time points

  From initiation of treatment through 12 months (every 9 weeks)

Study Arms (4)

DK210 (EGFR) Monotherapy (Dose escalation and expansion)

EXPERIMENTAL

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)

DK210 (EGFR) + chemotherapy

EXPERIMENTAL

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); Drug: Chemotherapy

DK210 (EGFR) + radiation

EXPERIMENTAL

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); Radiation: Radiation therapy

DK210 (EGFR) + immunotherapy

EXPERIMENTAL

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); Biological: Immune checkpoint blockers

Interventions

DK210 (EGFR) BIOLOGICAL

Solution for SC administration

DK210 (EGFR) + chemotherapy; DK210 (EGFR) + immunotherapy; DK210 (EGFR) + radiation; DK210 (EGFR) Monotherapy (Dose escalation and expansion)

Radiation therapy RADIATION

Short regimen radiation therapy (10 fractions or less)

DK210 (EGFR) + radiation

Immune checkpoint blockers BIOLOGICAL

IV administration of approved PD1 blocker

Also known as: Pembrolizumab, Nivolumab

DK210 (EGFR) + immunotherapy

Chemotherapy DRUG

Single agent or combination of not more than two

Also known as: Paclitaxel, Carboplatin, Oxaliplatin, Fluorouracil, Capecitabine

DK210 (EGFR) + chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DEKA Biosciences: lead

Study Sites (7)

City of Hope

Duarte, California, 91010, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

NEXT Oncology

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms; Skin Neoplasms; Kidney Neoplasms

Interventions

Radiotherapy; Immune Checkpoint Inhibitors; pembrolizumab; Nivolumab; Drug Therapy; Paclitaxel; Carboplatin; Oxaliplatin; Fluorouracil; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Medical Officer

  DEKA Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: January 30, 2023
• Study Start: April 3, 2023
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)