Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate safety, pharmacodynamics and biomarkers of subcutaneous (SC) DK210(EGFR) given as monotherapy and in combination with immunotherapy, chemotherapy or radiation.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DK210 (EGFR) | Biological | Solution for SC administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) with DK210 (EGFR) | Based on toxicities observed | Minimum of 90 days from initiation of experimental therapy |
| Identify recommended dose of DK210 (EGFR) | Based on toxicities observed | 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 | Minimum of 90 days from initiation of experimental therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Best response rate at 9 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Officer | DEKA Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Northwell Health |
At this time, IPD sharing has not been defined and/or decided if it will be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Radiation therapy | Radiation | Short regimen radiation therapy (10 fractions or less) |
|
| Immune checkpoint blockers | Biological | IV administration of approved PD1 blocker |
|
|
| Chemotherapy | Drug | Single agent or combination of not more than two |
|
|
Based on investigator clinical examination and review of radiographic images
| 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. | 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 | 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 | 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 | 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 | 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 | From initiation of treatment through 12 months (every 9 weeks) |
| Manhasset |
| New York |
| 11030 |
| United States |
| OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| The University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| NEXT Oncology | Fairfax | Virginia | 22031 | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D006258 | Head and Neck Neoplasms |
| D012878 | Skin Neoplasms |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000082082 | Immune Checkpoint Inhibitors |
| C582435 | pembrolizumab |
| D000077594 | Nivolumab |
| D004358 | Drug Therapy |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided