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

Purpose

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.

Conditions

  • Advanced Solid Tumor
  • Non Small Cell Lung Cancer
  • Untreated Advanced NSCLC
  • 1st Line NSCLC

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

  1. 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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1a: STK-012 monotherapy dose escalation 		STK-012 subcutaneous (SC) as monotherapy in selected solid tumor indications
  • Drug: STK-012
    Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
Experimental
Phase 1a: STK-012 + pembrolizumab dose escalation 		STK-012 SC + pembrolizumab intravenously (IV) in selected solid tumor indications
  • Drug: STK-012
    Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
  • Drug: pembrolizumab KEYTRUDA®
    anti-PD-1 monoclonal antibody
Experimental
Phase 1a: STK-012 + standard of care (SoC) dose escalation 		STK-012 SC + SoC IV in first-line non-squamous (NSQ) NSCLC
  • Drug: STK-012
    Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
  • Drug: pembrolizumab KEYTRUDA®
    anti-PD-1 monoclonal antibody
  • Drug: pemetrexed
    chemotherapy
  • Drug: carboplatin
    chemotherapy
Experimental
Phase 1b: STK-012 monotherapy expansion 		STK-012 SC monotherapy in selected solid tumor indications
  • Drug: STK-012
    Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
Experimental
Phase 1b: STK-012 + pembrolizumab dose expansion 		STK-012 SC will be administered in combination with pembrolizumab IV in selected solid tumor indications
  • Drug: STK-012
    Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
  • Drug: pembrolizumab KEYTRUDA®
    anti-PD-1 monoclonal antibody
Experimental
Phase 1b: STK-012 + SoC dose expansion 		STK-012 SC + SoC IV in first-line PD-L1 negative NSQ NSCLC
  • Drug: STK-012
    Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
  • Drug: pembrolizumab KEYTRUDA®
    anti-PD-1 monoclonal antibody
  • Drug: pemetrexed
    chemotherapy
  • Drug: carboplatin
    chemotherapy
Experimental
Phase 2: Arm A 		STK-012 2.25 mg SC Q3W + SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC
  • Drug: STK-012
    Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
  • Drug: pembrolizumab KEYTRUDA®
    anti-PD-1 monoclonal antibody
  • Drug: pemetrexed
    chemotherapy
  • Drug: carboplatin
    chemotherapy
Experimental
Phase 2: Arm B 		STK-012 1.5 mg SC Q3W + SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC
  • Drug: STK-012
    Engineered Interleukin-2 (IL-2) selective for antigen activated T cells
  • Drug: pembrolizumab KEYTRUDA®
    anti-PD-1 monoclonal antibody
  • Drug: pemetrexed
    chemotherapy
  • Drug: carboplatin
    chemotherapy
Active Comparator
Phase 2: Arm C 		SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC
  • Drug: pembrolizumab KEYTRUDA®
    anti-PD-1 monoclonal antibody
  • Drug: pemetrexed
    chemotherapy
  • Drug: carboplatin
    chemotherapy

Recruiting Locations

Georgetown University
Washington D.C., District of Columbia 20057

More Details

Status
Recruiting
Sponsor
Synthekine

Study Contact

Synthekine STK-012-101 Contact
650-606-6319
STK-012-101.contact@synthekine.com

Detailed Description

Phase 1: 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: 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 or STK11 mutated, non-squamous, non-small cell lung cancer. Subjects in the randomized Phase 2 portion (Part G) will be randomized 1:1:1 and stratified by tumor PD-L1 expression and STK11 mutation status.