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

Status
Active
Cancer Type
Head and Neck Cancer
Kidney Cancer
Lung Cancer
Melanoma
Ovarian Cancer
Solid Tumor
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05098132
Protocol IDs
STK-012-101 (primary)
NCI-2022-00633
Study Sponsor
Synthekine

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.

Objectives

The phase 1a portion of the study is a dose escalation design to evaluate STK-012 as
monotherapy and in combination therapy in patients with selected solid tumors. The phase
1b portion of the study includes dose expansions to evaluate STK-012 as monotherapy and
in combination therapy at the candidate recommended phase 2 dose (RP2D) in selected solid
tumor types.

Eligibility

  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

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.