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
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Study Summary
To assess the safety, efficacy and PK of STK-012 as monotherapy and in combination with pembrolizumab in patients with selected advanced solid tumors. To evaluate the safety, pharmacokinetics, immunogenicity, preliminary efficacy, and pharmacodynamics of STK-012 as monotherapy and in combination with pembrolizumab. Phase Ib: to evaluate STK-012 as monotherapy at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types, including renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC). Longitudinal blood samples at pretreatment, peak (Day8) and trough (Day21) of dosing cycles 1–3 were analyzed for STK-012 pharmacokinetics (PK), cytokines, and effects on immune cells. T-cell clonality was analyzed by TCR- sequencing pre/post a single dose of STK-012 (quantifying >10-fold expanding clones).
To investigate the safety and efficacy of STK-012 in combination with standard dose pembrolizumab and chemotherapy vs. the safety and efficacy of standard dose pembrolizumab and chemotherapy in patients with first-line, PD-L1 negative NSQ NSCLC.
To evaluate the safety, pharmacokinetics, immunogenicity, pharmacodynamics, and antitumor activity of STK-012 as monotherapy and in combination in subjects with advanced solid tumors
- Selected Inclusion Criteria:
- Phase 1: Selected advanced solid tumors
- 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
Clinical Study Information for Healthcare Providers
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