For Healthcare Professionals

STK-012 Monotherapy and in Combination Therapy in Patients with Solid Tumors

clipboard-pencil

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 therapy in patients with selected advanced solid tumors.
user-3

Who can take part

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

INCLUSION CRITERIA

Selected Inclusion Criteria:


  1. Participants enrolled to STK-012 monotherapy dose escalation and expansion and STK-012 + pembrolizumab combination dose escalation must have selected tumor types and progressed after standard of care treatment, or be intolerant to treatment, or refused standard treatment.
  2. Participants enrolled to STK-012 + pembrolizumab combination dose expansion must have selected tumor types and may not have received treatment for metastatic disease.
  3. Participants enrolled to STK-012 dose escalation combination treatment with pembrolizumab, pemetrexed and carboplatin must have NSCLC and may not have received treatment for metastatic disease.
  4. Participants enrolled to STK-012 dose expansion combination treatment with pembrolizumab, pemetrexed and carboplatin must have PD-L1 negative NSCLC and may not have received treatment for metastatic disease.

EXCLUSION CRITERIA

Selected Exclusion Criteria:


  1. 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.
  2. Received radiotherapy within 2 weeks of the first dose of study treatment.
  3. Received prior IL-2-based or IL-15-based cytokine therapy.
  4. Participants with NSCLC may not have any known actionable genetic aberrations with approved therapies.

pin location

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.
Phone iconCall 650-271-9888Email iconEmail Study Center

Study 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

18+

Phase

PHASE1

Participants Needed

202

Est. Completion Date

Oct 31, 2027

Treatment Type

INTERVENTIONAL


Sponsor

Synthekine

ClinicalTrials.gov NCT Identifier

NCT05098132

Study Number

STK-012-101

Understanding Clinical Trials


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

Interested?

Sign up to create a personal profile and 
receive news, resources, and alerts 
about clinical trials related to your conditions of interest.