Phase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors
Brain & Spinal Cord Tumor
Head and Neck Cancer
Kidney Cancer
Lung Cancer
Melanoma
Ovarian Cancer
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
STK-012-101 (primary)
NCI-2022-00633
Summary
This is a first-in-human, phase 1a/1b, multicenter, open-label, dose escalation study of
STK-012 as monotherapy and in combination with pembrolizumab in patients with selected
advanced solid tumors.
Objectives
The phase 1a portion of the study is standard 3+3 dose escalation design to evaluate STK-012
as monotherapy and in combination with pembrolizumab in patients with selected solid tumors
who have progressed after standard of care treatments. The phase 1b portion of the study
includes dose expansions to evaluate STK-012 as monotherapy and in combination with
pembrolizumab at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types.
Eligibility
- Patients must have selected tumor types and must have progressed after standard of care treatment, or be intolerant to treatment, or refused standard treatment.
- Patients must be amenable to a fresh tissue biopsy, unless medically contraindicated.
- Patients with central nervous system (CNS) metastases must have been treated and be asymptomatic.
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.