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New treatment option for Advanced Lung Non-Small Cell Carcinoma
Official title GT103 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic STK11 Mutant Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07017829
What this study is testing
What is Anti-CFH Monoclonal Antibody GT103?
Anti-CFH Monoclonal Antibody GT103 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced lung non-small cell carcinoma.
Also referred to as GT 103, GT-103.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Must have progressed on a pembrolizumab containing regimen and eligible for continuing pembrolizumab post-progression as determined by treating...
- Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L.
You likely can't join if
- 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. people must have recovered from all radiation related...
- Active/untreated brain metastasis. Whole brain radiation or gamma knife radiosurgery performed less than 4 weeks prior to first administration of...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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.
- Troponin-I ≤ ULN and B-type natriuretic peptide test (BNP) \< 200 pg/mL.
- 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...
- 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...
- 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...
What rules you out
- 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. people 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.