Open Actively Recruiting

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

About

Brief Summary

This is a phase 1/2, multicenter, open-label study. The phase 1 portion is a dose escalation and expansion study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors. The phase 2 portion is a randomized study of STK-012 in combination with standard of care (SoC) pembrolizumab, pemetrexed, and carboplatin versus SoC, in patients with first line, PD-L1 negative, non-squamous, non-small cell lung cancer.

Primary Purpose
The main objective of the intervention(s) being evaluated by the clinical trial. Learn more
Treatment
Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
Interventional
Phase
Phase 1

Eligibility

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

Selected Inclusion Criteria:

  • Phase 1 [closed to enrollment]
  • Phase 2 [open to enrollment]:
    • Diagnosis of non-small cell lung cancer (NSCLC).
    • Stage IV or Stage IIIB/IIIC and not a candidate for definitive treatment.
    • Non-squamous (NSQ) cell histology.
    • No prior systemic therapy for advanced/metastatic NSQ NSCLC.
    • Tumor is PD-L1 negative (TPS <1%) by local testing.
    • No known actionable EGFR, ALK, ROS1, or other actionable genomic aberrations for which there is a local standard of care available as front line therapy.

Selected Exclusion Criteria:

  • Phase 1 [closed to enrollment]
  • Phase 2 [open to enrollment]:
    • Prior immune checkpoint inhibitor (anti-PD[L]1 and/or anti-CTLA-4) treatment
    • Tumor with small cell, neuroendocrine, or sarcomatoid components.
    • Received radiotherapy ≤ 7 days of the first dose of study treatment.
    • Known untreated central nervous system metastases
    • Any history of carcinomatous meningitis

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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 Alhambra
  • UCLA Burbank
  • UCLA Irvine
  • UCLA Pasadena
  • UCLA Porter Ranch
  • UCLA San Luis Obispo
  • UCLA Santa Clarita
  • UCLA Santa Monica
  • UCLA Westlake Village
For Providers
NCT No.
NCT05098132
For detailed technical eligibility, visit ClinicalTrials.gov.