DK210 for Cancer
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: DEKA Biosciences
Must not be taking: Immunotherapies, Experimental therapies
Disqualifiers: Diffuse peritoneal disease, Prolonged QtC, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study will evaluate safety, pharmacodynamics and biomarkers of subcutaneous (SC) DK210(EGFR) given as monotherapy and in combination with immunotherapy, chemotherapy or radiation.
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.
Eligibility Criteria
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.
Additional criteria may apply
My cancer is worsening, shown by symptoms, tumor growth, or imaging.
+6 more
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
+3 more
Trial Timeline
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
Participant Groups
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.
4Treatment groups
Experimental Treatment
Group I: DK210 (EGFR) Monotherapy (Dose escalation and expansion)Experimental Treatment1 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) + radiationExperimental Treatment2 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) + immunotherapyExperimental Treatment2 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) + chemotherapyExperimental Treatment2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
OU Health Stephenson Cancer CenterOklahoma City, OK
NEXT OncologyFairfax, VA
City of HopeDuarte, CA
Mary Crowley Cancer ResearchDallas, TX
More Trial Locations
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Who Is Running the Clinical Trial?
DEKA BiosciencesLead Sponsor
References
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. [2022]Gefitinib was the first epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) approved for the treatment of advanced non-small cell lung cancer (NSCLC). Few treatment options are available for NSCLC patients who have responded to gefitinib treatment and demonstrated tumor progression. The present study was conducted to evaluate the efficacy and toxicity of the 2(nd) EGFR-TKI administration.
Phase I Trial of a Third Generation EGFR Mutant-Selective Inhibitor (D-0316) in Patients with Advanced Non-Small Cell Lung Cancer. [2022]D-0316 is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) developed for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR T790M mutation that progressed after prior treatment with the first- or second-generation EGFR-TKI.
First-Line EGFR-TKIs Treatment in Stage I Non-Small-Cell Lung Cancer Patients Harboring EGFR Gene Mutations with Postoperative Intrapulmonary Recurrence. [2022]The epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) is an effective treatment for advanced lung cancer harboring EGFR gene mutations, and has improved progression-free survival in several clinical trials.
Randomized Phase II Trial of Erlotinib Beyond Progression in Advanced Erlotinib-Responsive Non-Small Cell Lung Cancer. [2018]Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy is clearly beneficial in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC). However, acquired resistance develops uniformly and the benefit of continuation of EGFR TKI therapy beyond progression remains unclear.
Safety, efficacy, and pharmacokinetics of SH-1028 in EGFR T790M-positive advanced non-small cell lung cancer patients: A dose-escalation phase 1 study. [2023]SH-1028 is a new third-generation EGFR tyrosine kinase inhibitors (TKI) to benefit patients with EGFR T790M-mutated NSCLC. Here, the authors report its clinical safety, preliminary efficacy, and pharmacokinetic (PK) profile for the first time.
Dacomitinib for the treatment of advanced or metastatic non-small-cell lung cancer. [2019]Dacomitinib (PF-00299804) is a second-generation irreversible HER tyrosine kinase inhibitor (TKI). In preclinical studies, dacomitinib has demonstrated anti-tumor activity in lung cancer cell lines with sensitive and resistant EGFR mutations (including the T790 mutation). Safety and well tolerability of dacomitinib were demonstrated in Phase I studies with stomatitis, diarrhea and skin toxicities being the dose-limiting toxicities. The maximum tolerated dose was established to be 45 mg/day. In Phase II and III studies, dacomitinib has shown clinical activity in both HER tyrosine kinase-naive and HER tyrosine kinase failure settings. Further clinical trials are underway to evaluate the efficacy of dacomitinib in non-small-cell lung cancer.
Dacomitinib Beats Gefitinib for EGFR+ NSCLC. [2019]The irreversible EGFR inhibitor dacomitinib reduced the chance of lung cancer progression compared with an older, first-generation EGFR inhibitor, gefitinib, in a phase III trial. As reported at the 2017 American Society of Clinical Oncology Annual Meeting, the experimental drug also increased toxicity, which could limit its use, especially with a safer, more effective third-generation EGFR inhibitor not far behind in the development pipeline.
Gefitinib: a new antineoplastic for advanced non-small-cell lung cancer. [2019]The pharmacology, pharmacokinetics, and safety of gefitinib and its role in the management of non-small-cell lung cancer are reviewed.
Pooled safety analysis of EGFR-TKI treatment for EGFR mutation-positive non-small cell lung cancer. [2022]Three epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) - afatinib, erlotinib, and gefitinib - are available for the treatment of patients with EGFR mutation-positive non-small cell lung cancer (NSCLC). Given the long-term exposure of such patients to EGFR-TKIs, the toxicological properties of these agents in these individuals may differ from those observed in unselected patients. We compared the frequencies of severe adverse events (AEs) among EGFR mutation-positive NSCLC patients treated with these three EGFR-TKIs.