Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Skin Neoplasms

Carcinoma, Non-Small-Cell Lung

Head and Neck Neoplasms

Carcinoma, Renal Cell

Lung Neoplasms

Disease Progression

Kidney Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Analgesics

Nivolumab

Pembrolizumab

Paclitaxel

Albumin-Bound Paclitaxel

Oxaliplatin

Carboplatin

Fluorouracil

Capecitabine

Immune Checkpoint Inhibitors

Immunomodulating Agents

Interleukin-2

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

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.

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

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

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

DK210 (EGFR)

Short regimen radiation therapy (10 fractions or less)

Radiation therapy

IV administration of approved PD1 blocker

Immune checkpoint blockers

Single agent or combination of not more than two

Chemotherapy

DEKA Biosciences

Clinical Trials Coordinator

Abishek Tripathi, MD

Clinical Research

Xinhua Zhu, MD, PhD

Clinical Trials Office

Abdul Rafeh Naqash, MD

Douglas Orr, MD

Syed Kazmi, MD

Ashabari Sprenger, PhD

Siqing Fu, MD, PhD

Maryann Poole

Alex Spira, MD

Medical Officer

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).

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

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

At this time, IPD sharing has not been defined and/or decided if it will be shared.

Overall response rate (ORR) will be based on clinical examination and investigator review of radiographic images

Based on investigator clinical examination and review of radiographic images

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.

Time from first dose of DK210 (EGFR) to the time of death

Concentration vs time and standard pharmacokinetic (PK) parameters will be summarized by dose level

Spots Global Cancer Trial Database for immune checkpoint blockers