Synthekine STK-012 (Solid Tumors) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called STK-012 (the study drug) is a safe and effective treatment for different types of cancer.

What is the Condition Being Studied?

Advanced Solid Tumors

Who Can Participate in the Study?

Adults diagnosed with any of the following cancers that have spread:

- Non-small cell lung cancer (NSCLC)

- Head and neck squamous-cell carcinoma (HNSCC)

- Melanoma

- Renal cell carcinoma (RCC)

- Cervical cancer

- Urothelial carcinoma

- Gastric cancer

- Microsatellite instability-high or mismatch repair deficient cancers (MSI-H/dMMR)

For more information about who can join this study, please contact the study team at 919-681-6468.

Age Group

What is Involved?

If you choose to join this study, the study regimen you receive will depend on what part of the study you join. There are 4 parts to this study:

- In Part A, study participants will get the study drug on its own every week.

- In Part B, study participants will get the study drug on its own every 3 weeks.

- In Part C, study participants will get the study drug every 3 weeks in combination with pembrolizumab.

- In Part D, study participants will be assigned to get the study drug every 3 weeks either on its own or in combination with pembrolizumab.

Before you make a decision, the study doctor will let you know which part of the study is enrolling at the time.

Regardless of which part of the study you join, during this study you will also:

- Provide tumor tissue

- Have physical exams, blood draws, and give urine samples

- Have imaging scans (CT and MRI)

- Have heart tests (ECG)

Study Details

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
Principal Investigator
Christopher Hoimes
Protocol Number
IRB: PRO00110679
NCT: NCT05098132
Phase I/II
Enrollment Status
Open for Enrollment