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

February 9, 2024 updated by: DEKA Biosciences

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
          • Clinical Trials Coordinator
          • Phone Number: 626-218-1133
        • Principal Investigator:
          • Abishek Tripathi, MD
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health
        • Contact:
          • Clinical Research
          • Phone Number: 516-734-8896
        • Principal Investigator:
          • Xinhua Zhu, MD, PhD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OU Health Stephenson Cancer Center
        • Principal Investigator:
          • Abdul Rafeh Naqash, MD
        • Contact:
          • Clinical Trials Office
          • Phone Number: 405-271-8778
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern
        • Principal Investigator:
          • Syed Kazmi, MD
        • Contact:
          • Clinical Research
          • Phone Number: 833-722-6237
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Mary Crowley Cancer Research
        • Principal Investigator:
          • Douglas Orr, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas M.D. Anderson Cancer Center
        • Principal Investigator:
          • Siqing Fu, MD, PhD
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Next Oncology
        • Contact:
        • Principal Investigator:
          • Alex Spira, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Minimum of 90 days from initiation of experimental therapy
Based on toxicities observed
Minimum of 90 days from initiation of experimental therapy
Identify recommended dose of DK210 (EGFR)
Time Frame: Initiation of therapy up to day 90
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
Time Frame: Minimum of 90 days from initiation of experimental therapy
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)
Time Frame: Initiation of therapy up to approximately 12 months
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
Time Frame: Initiation of therapy through Day 63
Based on investigator clinical examination and review of radiographic images
Initiation of therapy through Day 63
Progression-free (PFS)
Time Frame: Study Day 1 until the date of first documented progression or date of death from any cause, assessed up to approximately 24 months
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 Frame: Assessed up to 24 months
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
Time Frame: From initiation of treatment through 12 months (every 9 weeks)
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
Time Frame: From initiation of treatment through 12 months (every 9 weeks)
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
Time Frame: From initiation of treatment through day 63
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
Time Frame: From initiation of treatment through 12 months (every 9 weeks)
Results will be summarized by dose level
From initiation of treatment through 12 months (every 9 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DEKA Biosciences

Investigators

  • Study Director: Medical Officer, DEKA Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

February 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)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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