Evaluating Safety and Biomarkers Using DK210 (EGFR) for Locally Advanced or Metastatic EGFR+ Tumors

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05704985
• Other study ID #: DEKA-1
• Status: Recruiting
• Phase: Phase 1
• Start date: April 3, 2023
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: DEKA Biosciences
• Contact: DEKA Biosciences
• Phone: 920-227-5115
• Email: clinical[@]dekabiosciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Colorectal Cancer
• Gynecologic Cancer
• Head and Neck Cancer
• Kidney Cancer
• Kidney Neoplasms
• Non Small Cell Lung Cancer
• Pancreas Cancer
• Pancreatic Neoplasms
• Skin Cancer
• Solid Tumor

Intervention

Biological:
• DK210 (EGFR)
Solution for SC administration

Radiation:
• Radiation therapy
Short regimen radiation therapy (10 fractions or less)

Biological:
• Immune checkpoint blockers
IV administration of approved PD1 blocker

Drug:
• Chemotherapy
Single agent or combination of not more than two

Locations

Country	Name	City	State
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	University of Texas Southwestern	Dallas	Texas
United States	City of Hope	Duarte	California
United States	NEXT Oncology	Fairfax	Virginia
United States	The University of Texas M.D. Anderson Cancer Center	Houston	Texas
United States	Northwell Health	Manhasset	New York
United States	OU Health Stephenson Cancer Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
DEKA Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs) with DK210 (EGFR)	Based on toxicities observed	Minimum of 90 days from initiation of experimental therapy
Primary	Identify recommended dose of DK210 (EGFR)	Based on toxicities observed	Initiation of therapy up to day 90
Primary	Incidence of Adverse Events (AE) of DK210 (EGFR) in combination with radiation, chemotherapy, or checkpoint blockers in Parts B, C, D	Based on toxicities observed	Minimum of 90 days from initiation of experimental therapy
Secondary	Overall response rate (ORR)	Overall response rate (ORR) will be based on clinical examination and investigator review of radiographic images	Initiation of therapy up to approximately 12 months
Secondary	Best response rate at 9 weeks	Based on investigator clinical examination and review of radiographic images	Initiation of therapy through Day 63
Secondary	Progression-free (PFS)	Time from first dose of DK210 (EGFR) to first documentation of clinical or radiographic disease progression or death due to any cause, whichever occurs first.	Study Day 1 until the date of first documented progression or date of death from any cause, assessed up to approximately 24 months
Secondary	Overall Survival (OS)	Time from first dose of DK210 (EGFR) to the time of death	Assessed up to 24 months
Secondary	Serum concentrations of DK210 (EGFR) will be determined at various time points	Concentration vs time and standard pharmacokinetic (PK) parameters will be summarized by dose level	From initiation of treatment through 12 months (every 9 weeks)
Secondary	Serum will be assayed for the presence of anti-DK210 (EGFR) antibodies	Results will be summarized by dose level	From initiation of treatment through 12 months (every 9 weeks)
Secondary	Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points	Results will be summarized by dose level	From initiation of treatment through day 63
Secondary	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	Results will be summarized by dose level	From initiation of treatment through 12 months (every 9 weeks)