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

About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Selected Inclusion Criteria

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.

EXCLUSION CRITERIA

Selected Exclusion Criteria:

Received systemic anti-cancer therapy within 3 weeks of the first dose of study treatment or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.
Received radiotherapy within 2 weeks of the first dose of study treatment.
Received prior IL-2-based or IL-15-based cytokine therapy.

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details

Contition

Advanced Solid Tumor,Non Small Cell Lung Cancer,Head and Neck Squamous Cell Carcinoma,Malignant Melanoma,Renal Cell Carcinoma,Cervical Cancer,Microsatellite Instability High,Gastric Cancer,GastroEsophageal Cancer,Urothelial Carcinoma,Mismatch Repair Deficiency

Age (in years)

18+

Phase

Phase 1

Participants needed

202

Est. Completion Date

Oct 31, 2025

Treatment type

Interventional

Sponsor

Synthekine

ClinicalTrials.gov identifier

NCT05098132

Study number

STK-012-101

Understanding Clinical Trials

Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?