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

Introduction

• Org Study ID: DEKA-1
• NTC ID: NCT05704985
• Lead Sponsor Name: DEKA Biosciences
• Status: RECRUITING

Conditions

• Renal Cell Carcinoma

Brief 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.

Eligibility Criteria

Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* Subjects with documented diffuse peritoneal disease or persistent abundant ascites
* Subjects with known prolonged QtC interval
* Concomitant or recent (