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.
Who Can Participate?
Eligibility
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)
What is Involved?
Description
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.
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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 as a Single Agent and in Combination Therapy in Subjects with Selected Advanced Solid Tumors
Principal Investigator
Christopher
Hoimes
Protocol Number
PRO00110679
NCT ID
NCT05098132
Phase
I/II
Enrollment Status
Open to Enrollment