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

Introduction

• Org Study ID: STK-012-101
• NTC ID: NCT05098132
• Lead Sponsor Name: Synthekine
• Status: RECRUITING

Conditions

• Renal Cell Carcinoma

Brief Summary

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.

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.