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

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 or STK11 mutated, non-squamous, non-small cell lung cancer.

Eligibility

Selected Inclusion Criteria:

1. Phase 1: Selected advanced solid tumors
2. Phase 2:

   * 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.
   * Must have a tumor that meets at least one of the following criteria on local testing:

     * PD-L1 negative (TPS \<1%), OR;
     * STK11 mutated on tumor tissue or ctDNA
   * 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:

2\. Phase 2:

* Prior immune checkpoint inhibitor (anti-PD\[L\]1 and/or anti-CTLA-4) treatment
* Rare tumor subtypes (mucinous histology or tumors with small cell, neuroendocrine, or sarcomatoid components).
* Received radiotherapy ≤ 7 days of the first dose of study treatment.
* Known active central nervous system metastases
* Any history of carcinomatous meningitis

Conditions6

Interventions5

Locations33 sites

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