A first-in-human study is assessing the safety, efficacy, and pharmacokinetics of DK210 as a monotherapy and in combination with immunotherapy, radiotherapy, or chemotherapy for patients with EGFR-expressing solid tumors.
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Trial Name: 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
ClinicalTrials.gov Identifier: NCT05704985
Sponsor: DEKA Biosciences
Recruitment Contact: DEKA Biosciences, 920-227-5115, clinical@dekabiosciences.com
Completion Date: February 2025
The first patient has been dosed with DK210 in a first-in-human, phase 1 clinical trial (NCT05704985) for patients with EGFR-expressing advanced solid tumors.1
“The Diakine™ platform combines the potent anti-cancer function of interleukin-2 [IL-2] with the inflammation-controlling function of interleukin-10 and targets these cytokines to the tumor,” Alexander Spira, MD, PhD, FACP, co-director of the Virginia Cancer Specialists Research Institute, told Targeted OncologyTM.
While IL-2 is known to be toxic, when it is coupled with IL-10, the toxicity is reduced, and its potency is increased. This leads to it being a more tolerable and effective treatment for patients. The agent is the first of several experimental therapeutics developed as part of Deka's platform of molecules to treat both cancer and inflammatory diseases.
The multicenter, dose-finding study is taking place at NEXT Oncology in Fairfax, Virginia and aims to determine the safety, efficacy, and pharmacodynamics of DK210 in patients with advanced solid tumors expressing EGFR. Additionally, investigators will evaluate possible biomarkers of response to DK210 in this patient population.
In the study, treatment with DK210 will be assessed as a monotherapyvia subcutaneous administration at a dose escalating from 0.025 mg/kg to 0.3 mg/kg, and in combination with immunotherapy, chemotherapy or radiation.2 Treatment will continue until unacceptable toxicity, disease progression, or withdrawal of consent. Following the determination of the optimal dose, an expansion cohort will assess the dose in parallel with the combination arms.
Patients aged 18 years and older who have failed at least 1 line of systemic therapy and have not been operated on or receiving anti-cancer medication for at least 4 weeks, have an ECOG performance status of 0-1, and a life expectancy of >3 months are eligible for enrollment in the trial. Other inclusion criteria are to have measurable disease, defined as at least 1 lesion measurable on CT/MRI or bone scan as defined by RECIST 1.1, confirmed progressive metastatic and/or locally advanced unresectable solid cancer with EGFR overexpression or amplification by local standard, progressive disease, and adequate cardiovascular, hematological, liver, and renal function.
If a patient has documented diffuse peritoneal disease or persistent abundant ascites with known prolonged QtC interval, have had concomitant or recent treatment with agents with anti-tumor activity, including immunotherapies, or experimental therapies, or major surgery within 4 weeks, radiation therapy for the treatment of metastases within less than 3 weeks, and radionuclide therapy for the treatment of metastases within 4 weeks prior to screening, they will be excluded from the trial. Additionally, patients with uncontrolled intercurrent illness including, but not limited to, ongoing and uncontrolled infections, multiple myeloma, multiple sclerosis, myasthenia gravis, or psychiatric illness/social situations will be excluded, as well as those with any other conditions that, in the investigator's opinion, might indicate they be unsuitable for the study.
The primary end points of the trial are to evaluate the incidence of adverse events of DK210 given alone or in combination with radiation, chemotherapy, or immunotherapy, and to identify the recommended dose of the agent based on toxicities observed. The secondary end points of the trial will assess overall response rate, progression-free survival, best response at 9 weeks, overall survival, and pharmacokinetics.
“The main goals of the trial are to establish the effective dose, tolerability, and efficacy across EGFR-expressing tumor types,” added Spira.
"We are beyond thrilled to begin the clinical trial of DK210 [EGFR], marking our first program to enter clinical development," said John Mumm, PhD, president and chief executive officer of Deka, in the press release.1 "Importantly, we anticipate that the results of the study will confirm the clinical safety, pharmacokinetics, exploratory efficacy and correlative biomarker responses to our first DiakineTM, establishing a solid foundation for the expanded use of this treatment in cancer patients."
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