Open Actively Recruiting

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

About

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 with pembrolizumab in patients with selected advanced solid tumors.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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.

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.

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Study Stats
Protocol No.
22-001830
Category
Cervical Cancer
Colorectal Cancer
Esophageal Cancer
Head and Neck Cancer
Kidney Cancer
Lung Cancer
Melanoma (Skin Cancer)
Ovarian Cancer
Prostate Cancer
Stomach Cancer
Uterine/Endometrial Cancer
Principal Investigator
Contact
Tina Tieu
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT05098132
For detailed technical eligibility, visit ClinicalTrials.gov.