DK210 for Cancer

Not currently recruiting at 6 trial locations

Overseen By DEKA Biosciences

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: DEKA Biosciences

Must not be taking: Immunotherapies, Experimental therapies

Disqualifiers: Diffuse peritoneal disease, Prolonged QtC, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer treatment called DK210 (EGFR) to evaluate its safety and effectiveness. The study examines DK210 alone and in combination with other cancer treatments, such as radiation therapy, immune checkpoint blockers (a type of immunotherapy), or chemotherapy. It targets individuals with certain solid tumors, like lung or colon cancer, who have not responded to previous treatments. Participants should have visible tumors on scans, and their condition should be worsening. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you have not received any anti-cancer medication for at least 4 weeks before starting. If you are currently on such treatments, you will need to stop them and wait for this period before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that DK210 (EGFR) is generally well-tolerated. Studies have demonstrated promising safety results, with most side effects being mild, such as injection site reactions (in 53% of patients), tiredness (41%), and fever (35%). These side effects are common and expected with many treatments.

When combined with radiation, immunotherapy, or chemotherapy, safety remains a priority. Combining DK210 with immunotherapy, such as immune checkpoint blockers, can enhance the immune system's ability to fight cancer. Although promising, immune therapies can sometimes cause immune-related side effects, which are being closely monitored.

In all treatment combinations, the study is in an early phase. The main goal is to ensure safety and understand how the drug works in the body. Participants in the trial help researchers learn more about potential risks and how to manage them. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard cancer treatments like chemotherapy, radiation, and immunotherapy, DK210 (EGFR) is unique because it targets the epidermal growth factor receptor (EGFR), which plays a crucial role in cancer cell growth. Researchers are excited about DK210 because it offers a more precise mechanism that may limit damage to healthy cells, potentially reducing side effects. Additionally, DK210 is administered subcutaneously, making it less invasive than traditional intravenous treatments. The combination approaches, pairing DK210 with radiation, chemotherapy, or immunotherapy, are designed to enhance the effectiveness of existing therapies, offering hope for improved outcomes in cancer treatment.

What evidence suggests that this trial's treatments could be effective for cancer?

Earlier research on DK210 (EGFR) showed promising results for cancer treatment. It boosted the immune system by increasing certain immune cells without causing serious side effects. This finding is significant because DK210 can help the body fight cancer without harmful reactions. In this trial, participants may receive DK210 as monotherapy or combined with other treatments. When used with radiation therapy, DK210 may enhance treatment effectiveness by strengthening the body's defense against tumors. In the combination arm with immunotherapy, DK210 is believed to work well with other cancer-fighting drugs to improve response. Additionally, when combined with chemotherapy, DK210 may offer a stronger attack on cancer cells. Overall, early findings suggest DK210 could be a valuable part of cancer treatment plans. ^{1 2 3 6 7}

Who Is on the Research Team?

Medical Officer

Principal Investigator

DEKA Biosciences

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic tumors that are EGFR positive and have worsened despite treatment. They must have tried at least one therapy, be in good overall health with proper organ function, and not be on recent cancer treatments. Participants need measurable disease, an ECOG performance status of 0-1, a life expectancy over three months, and agree to use contraception.

Inclusion Criteria

My cancer type is known to respond to specific treatments and has high EGFR expression.

My cancer is worsening, shown by symptoms, tumor growth, or imaging.

I have tried at least one cancer treatment without success and haven't had any cancer treatment or surgery in the last 4 weeks.

Exclusion Criteria

I haven't taken any cancer treatment or experimental therapy in the last 4 weeks.

I have widespread disease in my abdomen or persistent fluid buildup.

Any other conditions that, in the investigator's opinion, might indicate the subject to be unsuitable for the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DK210 (EGFR) as monotherapy or in combination with radiation, immunotherapy, or chemotherapy. Treatment continues until unacceptable toxicity, disease progression, or withdrawal of consent.

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue to be monitored for progression-free survival and overall survival

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Chemotherapy
• DK210 (EGFR)
• Immune checkpoint blockers
• Radiation therapy

Trial Overview The study tests DK210(EGFR), alone or with other therapies like immunotherapy, chemotherapy or radiation. It aims to assess safety and how the body responds to the drug by looking at certain biomarkers in patients with various types of solid tumors.

How Is the Trial Designed?

Group I: DK210 (EGFR) Monotherapy (Dose escalation and expansion) Experimental Treatment 1 Intervention

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.

Group II: DK210 (EGFR) + radiation Experimental Treatment 2 Interventions

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

Group III: DK210 (EGFR) + immunotherapy Experimental Treatment 2 Interventions

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

Group IV: DK210 (EGFR) + chemotherapy Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

DEKA Biosciences

Lead Sponsor

Trials

1

Recruited

60+

Published Research Related to This Trial

In a study of 11 patients with advanced non-small cell lung cancer who previously responded to gefitinib, re-treatment with a second EGFR-TKI (either gefitinib or erlotinib) resulted in a disease control rate of 73% and a median progression-free survival of 3.4 months.

The safety profile of the second EGFR-TKI treatment was acceptable, with toxicities similar to those experienced during initial gefitinib therapy, suggesting that re-treatment can be a viable option for patients who initially responded to gefitinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical responses to EGFR-tyrosine kinase inhibitor retreatment in non-small cell lung cancer patients who benefited from prior effective gefitinib therapy: a retrospective analysis. Watanabe, S., Tanaka, J., Ota, T., et al.[2022]

Dacomitinib is a second-generation irreversible HER tyrosine kinase inhibitor that has shown anti-tumor activity against lung cancer, including cases with resistant EGFR mutations like T790, based on preclinical studies.

In clinical trials, dacomitinib was well tolerated at a maximum dose of 45 mg/day, with manageable side effects such as stomatitis, diarrhea, and skin toxicities, demonstrating its potential effectiveness in treating both naive and resistant HER tyrosine kinase settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dacomitinib for the treatment of advanced or metastatic non-small-cell lung cancer. Mok, T., Lee, K., Tang, M., et al.[2019]

D-0316, a third-generation EGFR tyrosine kinase inhibitor, was found to be safe and well-tolerated in a phase I trial with 84 patients, with no maximum tolerated dose reached and most adverse events being mild (grade 1 or 2).

The drug demonstrated promising efficacy, with overall response rates of 33.3% and 45.5% at doses of 50 mg and 100 mg, respectively, and a median progression-free survival of 8.3 and 9.6 months, indicating its potential as an effective treatment for patients with NSCLC harboring the EGFR T790M mutation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I Trial of a Third Generation EGFR Mutant-Selective Inhibitor (D-0316) in Patients with Advanced Non-Small Cell Lung Cancer. Jian, H., Wang, K., Cheng, Y., et al.[2022]

Gefitinib is an effective treatment for patients with advanced non-small-cell lung cancer who have not responded to previous chemotherapy, showing a high response rate of 93% when used as a second- or third-line therapy.

While gefitinib improves quality of life and pulmonary symptoms, it does not provide additional survival benefits when combined with standard chemotherapy, and it carries risks of adverse effects, including severe interstitial lung disease in about 1% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gefitinib: a new antineoplastic for advanced non-small-cell lung cancer. Cersosimo, RJ.[2019]

In a pooled analysis of 21 clinical trials involving 1468 patients with EGFR mutation-positive non-small cell lung cancer, afatinib was found to cause significantly more severe adverse events, such as rash and diarrhea, compared to erlotinib and gefitinib.

Gefitinib was associated with a higher frequency of severe hepatotoxicity compared to the other two drugs, while the overall rates of severe interstitial lung disease were low and similar across all three EGFR-TKIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pooled safety analysis of EGFR-TKI treatment for EGFR mutation-positive non-small cell lung cancer. Takeda, M., Okamoto, I., Nakagawa, K.[2022]

In a randomized phase II study involving 46 patients with advanced EGFR-mutated non-small cell lung cancer, continuing erlotinib therapy beyond disease progression did not improve progression-free survival compared to chemotherapy alone, with median PFS of 4.4 months for the combination versus 5.5 months for chemotherapy alone.

The study found that patients receiving erlotinib alongside chemotherapy experienced significantly more toxicity without any added therapeutic benefit, suggesting that continuing erlotinib after progression is not advisable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Phase II Trial of Erlotinib Beyond Progression in Advanced Erlotinib-Responsive Non-Small Cell Lung Cancer. Halmos, B., Pennell, NA., Fu, P., et al.[2018]

In a clinical trial involving 20 patients with EGFR T790M-mutated non-small cell lung cancer (NSCLC), SH-1028 demonstrated manageable safety and promising antitumor activity, particularly at a dose of 200 mg once daily.

The overall objective response rate (ORR) was 40%, with a notable 75% ORR in the 200 mg cohort, indicating that SH-1028 could be an effective treatment option for patients who have progressed after previous EGFR TKI therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, efficacy, and pharmacokinetics of SH-1028 in EGFR T790M-positive advanced non-small cell lung cancer patients: A dose-escalation phase 1 study. He, J., Ma, P., Zhao, D., et al.[2023]

In a phase III trial, the irreversible EGFR inhibitor dacomitinib was found to be more effective than the first-generation EGFR inhibitor gefitinib in reducing lung cancer progression.

However, dacomitinib also increased toxicity levels, which may restrict its use compared to newer, safer, and more effective third-generation EGFR inhibitors that are in development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dacomitinib Beats Gefitinib for EGFR+ NSCLC. [2019]

In a study of 30 patients with stage I non-small-cell lung cancer and EGFR gene mutations, treatment with EGFR tyrosine kinase inhibitors (TKIs) resulted in a high objective response rate of 76.7% and a complete disease control rate of 100%.

The median progression-free survival (PFS) was 24.5 months, with significantly longer PFS in patients treated with icotinib compared to gefitinib (30.5 months vs 12.0 months), indicating that EGFR-TKIs are an effective treatment option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-Line EGFR-TKIs Treatment in Stage I Non-Small-Cell Lung Cancer Patients Harboring EGFR Gene Mutations with Postoperative Intrapulmonary Recurrence. Zhu, Z., Chai, Y.[2022]

Citations

1. withpower.com withpower.com/trial/phase-1-kidney-neoplasms-1-2023-97951

DK210 for Cancer · Info for Participants This study will evaluate safety, pharmacodynamics and biomarkers of subcutaneous (SC) DK210(EGFR) given as monotherapy and in combination with immunotherapy, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05704985

Evaluating Safety and Biomarkers Using DK210 (EGFR) for ... This study will evaluate DK210(EGFR) as monotherapy and combination in subjects with advanced solid EGFR expressing cancers with documented progressive disease ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2584

Safety and activity of Diakine DK210 (EGFR), a next ... These data suggest the EGFR targeted balanced combination of IL-2 with IL-10 improves safety and increases potency of anti-tumor function by dissociating CRS ...

4. targetedonc.com targetedonc.com/view/phase-1-trial-of-dk210-begins-dosing-patients-with-egfr-solid-tumors

Phase 1 Trial of DK210 Begins Dosing Patients With ... A first-in-human study is assessing the safety, efficacy, and pharmacokinetics of DK210 as a monotherapy and in combination with immunotherapy, radiotherapy, ...

5. onclive.com onclive.com/view/dk210-egfr-induces-immune-response-without-increased-crs-or-regulatory-t-cells-in-solid-tumors

DK210 (EGFR) Induces Immune Response Without ... DK210 (EGFR) showed evidence of wild-type IL-2 signaling, CRS mitigation, and immune response signaling in patients with solid tumors.

6. ascopubs.org ascopubs.org/doi/pdf/10.1200/JCO.2024.42.16_suppl.2584

Safety and activity of Diakine DK210 (EGFR), a next ... Treatment-related AEs (TRAEs; any grade) in $ 10% pts were injection site reactions (53%), fatigue (41%), fever (35%), nausea (29%), diarrhea (18%); the ...

7. dekabiosciences.com dekabiosciences.com/wp-content/uploads/2024/11/DEKA-1-Clinical-Poster_Final_SITC_06Nov2024-pk.pdf

DEKA-1-Clinical-Poster_Final_SITC_06Nov2024-pk.pdf • These data confirm the potent, balanced, and targeted hypothesized mechanism of action of DK210. (EGFR) in patients. • This proof of mechanism supports ...