FDA Clears IND of DK210 for EGFR-Overexpressing Solid Tumors


A first-in-human, multicenter, phase 1 clinical trial will begin to assess the safety, and biomarkers for response of DK210 in patients with advanced solid cancer who are overexpressing EGFR.

About the Phase 1 Study of DK210

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, kientopd@dekabiosciences.com

Completion Date: February 2025

The FDA has cleared an investigational new drug (IND) application for DK210 for the treatment of patients with locally advanced or metastatic EGFR-overexpressing solid malignancies, according to Deka Biosciences.1

DK210 is an experimental therapeutic treatment and the first experimental therapeutic developed as part of Deka's platform of molecules. The agent consists of 2 cytokines coupled onto a single chain variable fragment targeting system which works to enable the cytokines to accumulate more specifically in certain tissues. The cytokine combination increases potency and reduces toxicity while the targeting system improves the efficacy, safety, and manufacturability of the agent.

With this clearance, a first-in-human, multicenter, phase 1 clinical trial will begin. Investigators aim to assess the safety, and biomarkers for response of DK210 in patients with advanced solid cancer who are overexpressing EGFR. (NCT05704985).

"Obtaining FDA clearance for our company's first program to start clinical trials is a significant achievement," said John Mumm, MD, chief executive officer, and co-founder of Deka Biosciences, in the press release. "We are excited to move forward with the clinical development of DK210 and the potential it holds for positively impacting the lives of many [patients with cancer]."

In the trial, DK210 will be administered subcutaneously as monotherapy or in combination with chemotherapy, radiotherapy, or immunotherapy to patients with EGFR-overexpressing solid tumors.2 Primary end points of the study include incidence of adverse effects and identifying the recommended dose of DK201. Secondary end points include the overall response rate, progression-free survival, overall survival, and the pharmacokinetic profile of DK210.

Inclusion in the study is open to patients aged 18 years and older with a confirmed diagnosis of progressive metastatic or locally advanced unresectable solid cancer with EGFR overexpression or amplification. Patients must have an ECOG performance status of 0 or 1, measurable disease per RECIST v1.1 criteria, progressive disease at the time of study entry, adequate cardiovascular, hematological, liver, and renal function, and not have received anti-cancer medication for at least 4 weeks prior to the start of study treatment.

If a patient has documented diffuse peritoneal disease or persistent abundant ascites, they are ineligible for enrollment. Additionally, patients who have received anti-cancer treatment less than 4 weeks prior to beginning study treatment, had major surgery within 4 weeks prior to starting treatment, or had any uncontrolled intercurrent illness including COVID-19 and human immunodeficiency virus will be excluded from the study. If a patient has any other condition that the investigator may deem unsuitable, they will also be ineligible for enrollment.

The trial is expected to enroll approximately 60 patients. Currently the study completion date is set for February 2025.

Deka Biosciences receives FDA clearance of DK210 (EGFR) investigational new drug application. News release. Deka Biosciences. January 30, 2023. Accessed February 1, 2023. https://prn.to/3HpKR5Z
Evaluating safety and biomarkers using DK210 (EGFR) for locally advanced or metastatic EGFR+ tumors. ClinicalTrials.gov. Updated January 30, 2023. Accessed February 1, 2023. https://clinicaltrials.gov/ct2/show/NCT05704985?term=NCT05704985&draw=1&rank=1
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