Clinical trial NCT05704985: Evaluating Safety and Biomarkers Using DK210 (EGFR) for Locally Advanced or Metastatic EGFR+ Tumors
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
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
Lead sponsor: DEKA Biosciences
Sponsor class: INDUSTRY
First posted: 2023-01-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events (AEs) with DK210 (EGFR)
timeFrame: Minimum of 90 days from initiation of experimental therapy
measure: Identify recommended dose of DK210 (EGFR)
timeFrame: Initiation of therapy up to day 90
measure: Incidence of Adverse Events (AE) of DK210 (EGFR) in combination with radiation, chemotherapy, or checkpoint blockers in Parts B, C, D
timeFrame: Minimum of 90 days from initiation of experimental therapy
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: Initiation of therapy up to approximately 12 months
measure: Best response rate at 9 weeks
timeFrame: Initiation of therapy through Day 63
measure: Progression-free (PFS)
timeFrame: Study Day 1 until the date of first documented progression or date of death from any cause, assessed up to approximately 24 months
measure: Overall Survival (OS)
timeFrame: Assessed up to 24 months
measure: Serum concentrations of DK210 (EGFR) will be determined at various time points
timeFrame: From initiation of treatment through 12 months (every 9 weeks)
measure: Serum will be assayed for the presence of anti-DK210 (EGFR) antibodies
timeFrame: From initiation of treatment through 12 months (every 9 weeks)
measure: Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points
timeFrame: From initiation of treatment through day 63
measure: 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
timeFrame: From initiation of treatment through 12 months (every 9 weeks)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: Oklahoma City
country: United States
facility: OU Health Stephenson Cancer Center
state: Oklahoma
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: NEXT Oncology
state: Virginia
Study officials:
affiliation: DEKA Biosciences
name: Medical Officer
role: STUDY_DIRECTOR
References: