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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

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

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

Arm	Description	Assigned 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.