Trial Title:
Evaluating Safety and Biomarkers Using DK210 (EGFR) for Locally Advanced or Metastatic EGFR+ Tumors
NCT ID:
NCT05704985
Condition:
Cancer
Solid Tumor
Colorectal Cancer
Pancreas Cancer
Non Small Cell Lung Cancer
Head and Neck Cancer
Gynecologic Cancer
Skin Cancer
Kidney Cancer
Conditions: Official terms:
Kidney Neoplasms
Pancreatic Neoplasms
Paclitaxel
Carboplatin
Pembrolizumab
Capecitabine
Nivolumab
Oxaliplatin
Fluorouracil
Immune Checkpoint Inhibitors
Conditions: Keywords:
Cytokine
IL-2
Interleukin 2
IL-10
Interleukin 10
Oncology
Immuno-oncology
DK210(EGFR)
Immunotherapy
DEKA
DEKA Biosciences
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
DK210 (EGFR)
Description:
Solution for SC administration
Arm group label:
DK210 (EGFR) + chemotherapy
Arm group label:
DK210 (EGFR) + immunotherapy
Arm group label:
DK210 (EGFR) + radiation
Arm group label:
DK210 (EGFR) Monotherapy (Dose escalation and expansion)
Intervention type:
Radiation
Intervention name:
Radiation therapy
Description:
Short regimen radiation therapy (10 fractions or less)
Arm group label:
DK210 (EGFR) + radiation
Intervention type:
Biological
Intervention name:
Immune checkpoint blockers
Description:
IV administration of approved PD1 blocker
Arm group label:
DK210 (EGFR) + immunotherapy
Other name:
Pembrolizumab
Other name:
Nivolumab
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Single agent or combination of not more than two
Arm group label:
DK210 (EGFR) + chemotherapy
Other name:
Paclitaxel
Other name:
Carboplatin
Other name:
Oxaliplatin
Other name:
Fluorouracil
Other name:
Capecitabine
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Coordinator
Phone:
626-218-1133
Investigator:
Last name:
Abishek Tripathi, MD
Email:
Principal Investigator
Facility:
Name:
Northwell Health
Address:
City:
Manhasset
Zip:
11030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Research
Phone:
516-734-8896
Investigator:
Last name:
Xinhua Zhu, MD, PhD
Email:
Principal Investigator
Facility:
Name:
OU Health Stephenson Cancer Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Office
Phone:
405-271-8778
Investigator:
Last name:
Abdul Rafeh Naqash, MD
Email:
Principal Investigator
Facility:
Name:
Mary Crowley Cancer Research
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Recruiting
Contact:
Last name:
Douglas Orr, MD
Phone:
972-566-3000
Email:
referral@marycrowley.org
Investigator:
Last name:
Douglas Orr, MD
Email:
Principal Investigator
Facility:
Name:
University of Texas Southwestern
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Research
Phone:
833-722-6237
Investigator:
Last name:
Syed Kazmi, MD
Email:
Principal Investigator
Facility:
Name:
The University of Texas M.D. Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashabari Sprenger, PhD
Phone:
713-834-6993
Email:
amukherjee1@mdanderson.org
Investigator:
Last name:
Siqing Fu, MD, PhD
Email:
Principal Investigator
Facility:
Name:
NEXT Oncology
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maryann Poole
Phone:
703-280-5390
Email:
mpoole@nextoncology.com
Investigator:
Last name:
Alex Spira, MD
Email:
Principal Investigator
Start date:
April 3, 2023
Completion date:
February 2025
Lead sponsor:
Agency:
DEKA Biosciences
Agency class:
Industry
Source:
DEKA Biosciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05704985
