RecruitingPhase 2

GT103 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic STK11 Mutant Non-Small Cell Lung Cancer

A Phase II Trial of GT103 in Combination With Pembrolizumab in STK11 Mutant Non-Small Cell Lung Cancer (NSCLC)

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

  • Time periods mentioned: 2 years, 120 days
  • Procedures mentioned: Blood draws, MRI scans, CT scans, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity."
  • "Patients undergo echocardiography (ECHO) at baseline, magnetic resonance imaging (MRI) at baseline and as clinically indicated, and computed tomography (CT) and blood sample collection throughout the study."
  • "Patients may also undergo biopsy throughout the study."
  • "After completion of study treatment, patients are followed up every 30 days for 120 days."
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

In plain language

This study tests GT103 with pembrolizumab for adults with non-small cell lung cancer that has spread nearby or to other parts of the body and has a change in the STK11 gene. It looks at whether these drugs work together against the cancer after it has grown during treatment with pembrolizumab or a similar drug.

This phase II trial tests how well GT103 in combination with pembrolizumab works in treating patients with STK11 mutant non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). GT103 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. GT103 targets the tumor cell-protein complement factor H found on some cancer cells and may provide specific anti-tumor activity that may help block the formation of growths that may become cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving GT103 in combination with pembrolizumab may kill more cancer cells and improve outcomes in patients with advanced or metastatic STK11 mutant 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

Who can join

  • Be age 18 or older and able to do daily tasks with little or no help.
  • Have non-small cell lung cancer with an STK11 gene change confirmed by approved lab testing.
  • Have cancer that grew during treatment with pembrolizumab or a similar immune therapy. Your doctor must decide you can continue pembrolizumab.
  • Have blood counts and kidney, liver, and heart function that meet the study's limits.
  • Have cancer that can be measured on scans.
  • Agree to use birth control before joining if you can become pregnant.
  • Understand the study and sign a consent form before any study procedures.
  • Agree to give blood samples during the study and provide a new or stored tumor tissue sample.

Who can't join

  • Recent chemotherapy within 4 weeks, radiation outside the brain within 2 weeks, or major surgery within 14 days before study treatment. You must also recover from radiation and major surgery side effects.
  • Active or untreated cancer in the brain, brain radiation within 4 weeks, or cancer in the lining around the brain or spinal cord. Treated brain cancer must be stable on scans for at least 4 weeks after radiation and not need steroids.
  • Cancer with a growth-driving change in the EGFR, ALK, ROS1, RET, MET, or NTRK genes.
  • A past disease where the immune system attacks the body, a disease that weakens immunity, or recent drugs that weaken immunity. Some skin conditions, hormone-related conditions, and short courses of steroids are allowed.
  • A serious active infection, uncontrolled illness, certain serious heart problems, very high blood pressure despite treatment, or an allergy to the study drugs or similar drugs.
  • Another invasive cancer diagnosed within 2 years. Exceptions include certain skin, prostate, and early breast cancers, and cancers that have not spread beyond where they started.
  • Being pregnant or breastfeeding.
  • Being unable or unwilling to follow study rules, or having a condition or treatment that the study doctor thinks makes joining unsafe or could affect study results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age ≥ 18 years. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at the time of study treatment initiation. * Have pathologically confirmed diagnosis of STK11 mutant NSCLC. STK11 mutation will be based on subject's local clinically accredited laboratory testing (Clinical Laboratory Improvement Amendments \[CLIA\]-certified) using deoxyribonucleic acid (DNA) sequencing test. * Must have progressed on a pembrolizumab containing regimen and eligible for continuing pembrolizumab post-progression as determined by treating physician. Other anti-PD-1 or anti-PD-L1 checkpoint inhibitors may also be used in place of pembrolizumab * Adequate bone marrow and organ function as defined by the following lab values: * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L. * Platelets ≥ 100 x 10\^9/L. * Hemoglobin ≥ 9 g/dL. * Estimated glomerular filtration rate (GFR) (measured or calculated with Cockroft and Gault formula) \> 45mL/min. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) (ALT and AST ≤ 5 x ULN is acceptable if liver metastases are present). * Total bilirubin ≤ 1.5 x ULN. For patients with well documented Gilbert's syndrome, total bilirubin ≤ 3 x ULN with direct bilirubin within normal range. * Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (LLN) (institutional limit). * Patients must have measurable disease as defined in Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. * Participant agrees to provide blood samples at the start of treatment and at multiple times during the study. Participant agrees to provide tumor biopsy tissue or have adequate archival formalin-fixed paraffin-embedded (FFPE) tissue available. Exclusion Criteria: * Receipt of anticancer chemotherapy within 4 weeks before the first administration of study drug. * Prior radiotherapy or gamma knife within 2 weeks of study treatment for non-brain metastasis. Subjects must have recovered from all radiation related toxicities. * Active/untreated brain metastasis. Whole brain radiation or gamma knife radiosurgery performed less than 4 weeks prior to first administration of study drug. Previously treated brain metastasis allowed as long as not requiring steroids and stable on imaging at least 4 weeks after completing radiation therapy. * Leptomeningeal involvement regardless of treatment status. * Tumor with oncogenic mutation based on standard of care broad genomic profiling in EGFR, ALK, ROS1, RET, MET, or NTRK genes. * History of autoimmune disorder, with exception of patients with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation who are eligible. Systemic use of immunosuppressant drugs such as steroids (except as hormone replacement therapy or short-course supportive medication such as chemotherapy or drug allergy, etc.), azathioprine, tacrolimus, cyclosporine, etc. within 4 weeks before the first administration of study drug. * Currently receiving or has received systemic corticosteroids within 4 weeks prior to starting study drug for management of brain metastases, or who have not fully recovered from side effects of such treatment. Steroids for endocrine replacement or receipt of short-course of steroids during the preceding 4 week period as supportive medication such as for drug allergy, anti-emetic, etc. is allowed. * Had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery. * Has known immunosuppressive disease (e.g., HIV, AIDS or other immune depressing disease). Testing is not mandatory. * Active, clinically serious infections or other serious uncontrolled medical conditions. * Patient has known hypersensitivity to the components of the study drugs or any analogs. * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator, including, but not limited to: * Myocardial infarction or arterial thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease. * History of documented congestive heart failure (New York Heart Association functional classification III or IV) within 6 months prior to baseline. * Uncontrolled hypertension (systolic blood pressure \[SBP\] \> 160/diastolic blood pressure \[DBP\] \> 100 despite medical intervention). * History of myocarditis of any etiology. * History of ventricular arrhythmias. * Patients diagnosed with an invasive cancer within 2 years prior to starting protocol therapy with the following exceptions: non-melanoma skin cancers, in-situ cancers, and prostate cancer Gleason ≤ 6 (under surveillance or treated), early-stage node-negative estrogen receptor positive (ER+)/progesterone receptor positive (PR+) breast cancer with Oncotype Dx score \< 25 not taking adjuvant hormonal therapy. * Pregnant or nursing female participants. * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug. * Unwilling or unable to follow protocol requirements.

Study sites (1)

NY