RightFit
RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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

Study sites (33)

AZ

CA

CT

DC

GA

IL

MA

MD

MN

NC

NY

OH

OR

PA

TN

TX

VA

WA