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

Launched by SYNTHEKINE · Oct 20, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called STK-012 for patients with certain advanced solid tumors, which are types of cancer that form in various organs. The trial will test STK-012 both on its own and in combination with another medication called pembrolizumab. This is an early-stage study, meaning it's one of the first times this treatment is being tested in people. It is open to patients who have already tried standard treatments for their cancer but did not see improvements, could not continue with those treatments, or chose not to undergo them.

To participate, patients need to have specific types of cancer and should be willing to have a small tissue sample taken for testing. They should also be free of severe symptoms related to brain cancer if they have that type. Participants will be monitored closely throughout the trial and may receive regular visits to the clinic. This study is still recruiting patients, and it's an important step in finding new treatment options for those with difficult-to-treat cancers.

Gender

ALL

Eligibility 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.
• 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.