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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

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