A Phase I Study of STK-012 Alone and with Pembrolizumab Immunotherapy in People with Solid Tumors

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Full Title

A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 Monotherapy and in Combination with Pembrolizumab in Subjects with Selected Advanced Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug STK-012 that can be given safely in combination with pembrolizumab immunotherapy to people with solid tumors that have spread or come back despite prior treatment. STK-012 is a modified form of a protein called interleukin-2, which is normally made by the immune system. It may help to multiply and activate tumor-killing cells of the immune system.

Pembrolizumab takes the brakes off the immune response, boosting the ability of the immune system to detect and destroy cancer cells. Researchers believe both drugs used together may be more effective against advanced solid tumors than either one alone. STK-012 is given as a subcutaneous (under the skin) injection and pembrolizumab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have recurrent or metastatic non-small cell lung cancer, head and neck squamous cell cancer, malignant melanoma, renal cell carcinoma, ovarian cancer, cervical cancer, or a cancer that is described as microsatellite instability-high or mismatch repair deficient (it has many genetic mutations and/or a defect in the ability to correct mistakes that occur when genes are copied in the cell).
  • Patients’ cancers must continue to grow despite prior treatment.
  • The serious side effects of previous therapies must go away before the study treatment is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Dmitriy Zamarin at 646-888-4593.

Protocol

22-166

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

Diseases