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

a study on Solid Tumor Lung Cancer Non-Small Cell Lung Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
study ends around

Description

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.

Official Title

A Phase 1/2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects With Front-line Advanced NSCLC and Other Selected Indications

Details

Phase 1 [closed to enrollment]: The phase 1a portion is a dose escalation study to evaluate STK-012 as monotherapy and in combination therapy in patients with selected solid tumors. The phase 1b portion is a dose expansion study to evaluate STK-012 as monotherapy and in combination therapy at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types.

Phase 2 [open to enrollment]: The phase 2 portion is a randomized, open label study to evaluate STK-012 at two dose levels 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.

Keywords

Advanced Solid Tumor, Non Small Cell Lung Cancer, Untreated Advanced NSCLC, 1st Line NSCLC, Non-Small-Cell Lung Carcinoma, pembrolizumab, Pemetrexed, Carboplatin, STK-012, STK-012 monotherapy expansion

Eligibility

For people ages 18 years and up

Selected Inclusion Criteria:

  1. Phase 1 [closed to enrollment]
  2. 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:

  1. Phase 1 [closed to enrollment]
  2. 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

Locations

  • UC San Diego Moores Cancer Center in progress, not accepting new patients
    La Jolla California 92093-0698 United States
  • UCLA Hematology/Oncology - Santa Monica accepting new patients
    Santa Monica California 90404 United States
  • Beverly Hills Cancer Center accepting new patients
    Beverly Hills California 90211 United States
  • Hoag Memorial Hospital Presbyterian accepting new patients
    Newport Beach California 92663 United States
  • Providence Medical Foundation accepting new patients
    Fullerton California 92835 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Synthekine
ID
NCT05098132
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 364 study participants
Last Updated
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