ACTIVE_NOT_RECRUITING

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

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Conditions

CancerSolid TumorColorectal CancerPancreas CancerNon Small Cell Lung CancerHead and Neck CancerGynecologic CancerSkin CancerKidney CancerCytokineIL-2Interleukin 2IL-10Interleukin 10OncologyImmuno-oncologyDK210(EGFR)ImmunotherapyDEKADEKA Biosciences

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-04-03
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05704985

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ECOG performance status of 0-1
  2. * Life expectancy of \>3 months according to the investigator's judgment
  3. * 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
  4. * Measurable disease, defined as at least one (non-irradiated) lesion measurable on CT/MRI or bone scan as defined by RECIST 1.1.
  5. * Progressive disease (PD) at study entry defined as one or more of the following criteria:
  6. * Clinical PD with performance decline, clinical symptoms and/or observed tumor growth
  7. * PD documented with imaging showing at least 20% growth (largest diameter) and/or new lesions
  8. * Adequate cardiovascular, hematological, liver, and renal function.
  9. * 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.
  10. * Males and females of childbearing potential must agree to use effective contraception starting prior to the first day of treatment and continuing during treatment
  11. * Additional criteria may apply
  1. * Subjects with documented diffuse peritoneal disease or persistent abundant ascites
  2. * Subjects with known prolonged QtC interval
  3. * 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
  4. * 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
  5. * 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
  6. * Any other conditions that, in the investigator's opinion, might indicate the subject to be unsuitable for the study
  7. * Additional criteria may apply

Contacts and Locations

Principal Investigator

Medical Officer
STUDY_DIRECTOR
DEKA Biosciences

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: DEKA Biosciences

  • Medical Officer, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2023-04-03
Study Completion Date2025-10

Study Record Updates

Study Start Date2023-04-03
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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