CancerPhase 1NCT05704985
Evaluating Safety and Biomarkers Using DK210 (EGFR) for Locally Advanced or Metastatic EGFR+ Tumors
A Phase 1 study testing DK210 (EGFR), Radiation therapy and Immune checkpoint blockers in people with Cancer and Solid Tumor, run by DEKA Biosciences at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumor, Colorectal Cancer
- What is being tested?
- DK210 (EGFR), Radiation therapy and Immune checkpoint blockers
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 7 sitesUnited States
- Study dates
- 3 Apr 2023to Oct 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Mary Crowley Cancer Research
Dallas, Texas, 75230
University of Texas Southwestern
Dallas, Texas, 75390
City of Hope
Duarte, California, 91010
NEXT Oncology
Fairfax, Virginia, 22031
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Northwell Health
Manhasset, New York, 11030
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
About this study
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
This study will evaluate safety, pharmacodynamics and biomarkers of subcutaneous (SC) DK210(EGFR) given as monotherapy and in combination with immunotherapy, chemotherapy or radiation.
Read the 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).
- Conditions
- Cancer, Solid Tumor, Colorectal Cancer, Pancreas Cancer, Non Small Cell Lung Cancer, Head and Neck Cancer
- Being tested
- DK210 (EGFR), Radiation therapy, Immune checkpoint blockers, Chemotherapy
- Keywords
- Cytokine, IL-2, Interleukin 2, IL-10, Interleukin 10, Oncology, Immuno-oncology, DK210(EGFR), Immunotherapy, DEKA, DEKA Biosciences
- Medical subject headings
- Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms, Skin Neoplasms, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DK210 (EGFR)Biological
Solution for SC administration
Radiation therapyRadiation
Short regimen radiation therapy (10 fractions or less)
Immune checkpoint blockersBiological
Also called Pembrolizumab, Nivolumab
IV administration of approved PD1 blocker
ChemotherapyDrug
Also called Paclitaxel, Carboplatin, Oxaliplatin, Fluorouracil
Single agent or combination of not more than two
| Study group | Role | What they receive |
|---|---|---|
| DK210 (EGFR) Monotherapy (Dose escalation and expansion) | Experimental | DK210 (EGFR) will be administered as monotherapy three times per week via subcutaneous (SC) administration. Dose will be escalated from 0.025 mg/kg to 0.3 mg/kg or until unacceptable toxicity, disease progression, or withdrawal of consent. An expansion cohort at the optimal dose will be enrolled in parallel with the combination arms. Receives: Biological: DK210 (EGFR) |
| DK210 (EGFR) + chemotherapy | Experimental | In patients with good tolerance of first line systemic therapy, DK210 (EGFR) will be administered three times per week via subcutaneous (SC) administration in combination with second-line intravenous (IV) chemotherapy until unacceptable toxicity, disease progression, or withdrawal of consent Receives: Biological: DK210 (EGFR); Drug: Chemotherapy |
| DK210 (EGFR) + radiation | Experimental | In patients with need of palliative radiation, DK210 (EGFR) will be administered three times per week via subcutaneous (SC) administration in combination with short course radiation therapy (10 fractions or less) until unacceptable toxicity, disease progression, or withdrawal of consent Receives: Biological: DK210 (EGFR); Radiation: Radiation therapy |
| DK210 (EGFR) + immunotherapy | Experimental | In patients with good tolerance of first line immunotherapy, DK210 (EGFR) will be administered three times per week via subcutaneous (SC) administration in combination with intravenous (IV) immune checkpoint blockers until unacceptable toxicity, disease progression, or withdrawal of consent Receives: Biological: DK210 (EGFR); Biological: Immune checkpoint blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) with DK210 (EGFR)
Based on toxicities observed
Measured: Minimum of 90 days from initiation of experimental therapy
Identify recommended dose of DK210 (EGFR)
Based on toxicities observed
Measured: Initiation of therapy up to day 90
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
Measured: Minimum of 90 days from initiation of experimental therapy
Secondary outcomes (8)
Overall response rate (ORR)
Overall response rate (ORR) will be based on clinical examination and investigator review of radiographic images
Measured: Initiation of therapy up to approximately 12 months
Best response rate at 9 weeks
Based on investigator clinical examination and review of radiographic images
Measured: Initiation of therapy through Day 63
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.
Measured: Study Day 1 until the date of first documented progression or date of death from any cause, assessed up to approximately 24 months
Overall Survival (OS)
Time from first dose of DK210 (EGFR) to the time of death
Measured: Assessed up to 24 months
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
Measured: From initiation of treatment through 12 months (every 9 weeks)
Serum will be assayed for the presence of anti-DK210 (EGFR) antibodies
Results will be summarized by dose level
Measured: From initiation of treatment through 12 months (every 9 weeks)
Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points
Results will be summarized by dose level
Measured: From initiation of treatment through day 63
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
Measured: From initiation of treatment through 12 months (every 9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start3 Apr 2023
- Primary completionJul 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- DEKA Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Officer, Study director, DEKA Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704985
- Sponsor's protocol ID
- DEKA-1
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2023
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, IPD sharing has not been defined and/or decided if it will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05704985
- Acronym / sponsor ID
- DEKA-1
- Conditions
- Cancer, Solid Tumor, Colorectal Cancer, Pancreas Cancer, Non Small Cell Lung Cancer, Head and Neck Cancer
- Keywords
- Cytokine, IL-2, Interleukin 2, IL-10, Interleukin 10, Oncology, Immuno-oncology, DK210(EGFR)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- DEKA BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DK210 (EGFR) Monotherapy (Dose escalation and expansion) | Experimental | Biological: DK210 (EGFR)DK210 (EGFR) will be administered as monotherapy three times per week via subcutaneous (SC) administration. Dose will be escalated from 0.025 mg/kg to 0.3 mg/kg or until unacceptable toxicity, disease progression, or withdrawal of consent. An expansion cohort at the optimal dose will be enrolled in parallel with the combination arms. |
| DK210 (EGFR) + chemotherapy | Experimental | Biological: DK210 (EGFR), Drug: ChemotherapyIn patients with good tolerance of first line systemic therapy, DK210 (EGFR) will be administered three times per week via subcutaneous (SC) administration in combination with second-line intravenous (IV) chemotherapy until unacceptable toxicity, disease progression, or withdrawal of consent |
| DK210 (EGFR) + radiation | Experimental | Biological: DK210 (EGFR), Radiation: Radiation therapyIn patients with need of palliative radiation, DK210 (EGFR) will be administered three times per week via subcutaneous (SC) administration in combination with short course radiation therapy (10 fractions or less) until unacceptable toxicity, disease progression, or withdrawal of consent |
| DK210 (EGFR) + immunotherapy | Experimental | Biological: DK210 (EGFR), Biological: Immune checkpoint blockersIn patients with good tolerance of first line immunotherapy, DK210 (EGFR) will be administered three times per week via subcutaneous (SC) administration in combination with intravenous (IV) immune checkpoint blockers until unacceptable toxicity, disease progression, or withdrawal of consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DK210 (EGFR)Solution for SC administration | Biological | DK210 (EGFR) + chemotherapy, DK210 (EGFR) + immunotherapy, DK210 (EGFR) + radiation, DK210 (EGFR) Monotherapy (Dose escalation and expansion) |
| Radiation therapyShort regimen radiation therapy (10 fractions or less) | Radiation | DK210 (EGFR) + radiation |
| Immune checkpoint blockersAlso: Pembrolizumab, NivolumabIV administration of approved PD1 blocker | Biological | DK210 (EGFR) + immunotherapy |
| ChemotherapyAlso: Paclitaxel, Carboplatin, Oxaliplatin, FluorouracilSingle agent or combination of not more than two | Drug | DK210 (EGFR) + chemotherapy |
Primary outcome
Incidence of Adverse Events (AEs) with DK210 (EGFR)
Time frame: Minimum of 90 days from initiation of experimental therapy
Based on toxicities observed
Identify recommended dose of DK210 (EGFR)
Time frame: Initiation of therapy up to day 90
Based on toxicities observed
Incidence of Adverse Events (AE) of DK210 (EGFR) in combination with radiation, chemotherapy, or checkpoint blockers in Parts B, C, D
Time frame: Minimum of 90 days from initiation of experimental therapy
Based on toxicities observed
8 secondary outcomes
Overall response rate (ORR)
Time frame: Initiation of therapy up to approximately 12 months
Best response rate at 9 weeks
Time frame: Initiation of therapy through Day 63
Progression-free (PFS)
Time frame: Study Day 1 until the date of first documented progression or date of death from any cause, assessed up to approximately 24 months
Overall Survival (OS)
Time frame: Assessed up to 24 months
Serum concentrations of DK210 (EGFR) will be determined at various time points
Time frame: From initiation of treatment through 12 months (every 9 weeks)
Serum will be assayed for the presence of anti-DK210 (EGFR) antibodies
Time frame: From initiation of treatment through 12 months (every 9 weeks)
Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points
Time frame: From initiation of treatment through day 63
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
Time frame: From initiation of treatment through 12 months (every 9 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No. At this time, IPD sharing has not been defined and/or decided if it will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Officer study director
DEKA Biosciences
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DK210 (EGFR), Radiation therapy and Immune checkpoint blockers in people with Cancer and Solid Tumor, run by DEKA Biosciences at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) with DK210 (EGFR) (time frame: Minimum of 90 days from initiation of experimental therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.