Phase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor Head and Neck Cancer Kidney Cancer Lung Cancer Melanoma Ovarian Cancer Solid Tumor Unknown Primary	NCT ID:	NCT05098132
Trial Phases:	Phase I	Protocol IDs:	STK-012-101 (primary) NCI-2022-00633
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Synthekine
NCI Full Details:	http://clinicaltrials.gov/show/NCT05098132

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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