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

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DEKA Biosciences
• Treatments: Capecitabine; Carboplatin; Fluorouracil; Immune Checkpoint Inhibitors; Nivolumab; Oxaliplatin; Paclitaxel; Pembrolizumab

Criteria

Inclusion Criteria:

• ECOG performance status of 0-1

• Life expectancy of >3 months according to the investigator's judgment

• By local standard confirmed progressive metastatic and/or locally advanced unresectable solid cancer with EGFR overexpression or amplification

• 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 (<4 weeks or 5 half-lives of the last treatment, whichever is shorter) treatment with agents with anti-tumor activity, including immunotherapies, or experimental therapies. Bone treatments and supportive care can be continued

• Major surgery within 4 weeks, Radiation therapy for the treatment of metastases within less than 3 weeks (if single fraction of radiotherapy, then within 2 weeks) and radionuclide therapy for the treatment of metastases within 4 weeks prior to screening

• Uncontrolled intercurrent illness including, but not limited to, ongoing and uncontrolled infection (TBC, COVID or HIV patients treated with at least two anti-retroviral drugs and control of their infection with at least 500 /mm3 CD4+ T-cells in their blood and patients cured from Hepatitis B or C (i.e negativity of PCR) and liver function compatible with eligibility criteria are allowed to participate), multiple myeloma, multiple sclerosis, myasthenia gravis, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirement

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

• Additional criteria may apply