Not currently recruiting at UCSD

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 La Jolla, California and other locations
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
  • 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 at some sites,
but this study is not currently recruiting here
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