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Advanced Lung Non-Small Cell CarcinomaPhase 2NCT07017829

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

A Phase 2 study testing Anti-CFH Monoclonal Antibody GT103, Biopsy Procedure and Biospecimen Collection in people with Advanced Lung Non-Small Cell Carcinoma and Metastatic Lung Non-Small Cell Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Anti-CFH Monoclonal Antibody GT103, Biopsy Procedure and Biospecimen Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
1 Apr 2026to 1 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Edwin H. Yau, 716-845-5994, Edwin.Yau@roswellpark.org

    Edwin H. Yau

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the 6-month (24 week) progression-free survival (PFS) rate of anti-CFH monoclonal antibody GT103 (GT103) in combination with pembrolizumab in patients with advanced/metastatic STK11 mutant non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

  1. To evaluate secondary efficacy endpoints (i.e., investigator-assessed objective response rate, 12-month survival rate, overall survival, duration of response, and disease control rate) of GT103 in combination with pembrolizumab in patients with advanced/metastatic STK11 mutant NSCLC.

II. To evaluate the safety and tolerability of GT103 in combination with pembrolizumab in advanced/metastatic STK11 mutant NSCLC.

EXPLORATORY OBJECTIVES:

  1. To evaluate the effects of GT103 in combination with pembrolizumab on the tumor microenvironment.

II. To explore study tissue and blood-based biomarkers as potential predictors of treatment efficacy.

OUTLINE:

Patients receive GT103 intravenously (IV) over 60 minutes and pembrolizumab IV over 30 minutes on day 1 of each cycle. 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.

Being tested
Anti-CFH Monoclonal Antibody GT103, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Echocardiography Test
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-CFH Monoclonal Antibody GT103Biological

    Also called GT 103, GT-103, GT103

    Given IV

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo tumor biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Echocardiography TestProcedure or surgery

    Also called EC, Echocardiography

    Undergo ECHO

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • PembrolizumabBiological

    Also called BCD-201, GME 751, GME751, Keytruda

    Given IV

Study groups in NCT07017829
Study groupRoleWhat they receive
Treatment (GT103, pembrolizumab)ExperimentalPatients receive GT103 IV over 60 minutes and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO at baseline, MRI at baseline and as clinically indicated, and CT and blood sample collection throughout the study. Patients may also undergo biopsy throughout the study.
Receives: Biological: Anti-CFH Monoclonal Antibody GT103; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Will be summarized using standard Kaplan-Meier methods, where estimates will be obtained with 90% confidence intervals.

    Measured: Between study registration and documentation of disease progression or death, whichever is observed first, assessed up to 6 months (24 weeks)

Secondary outcomes (5)

  1. Objective response rate

    Will be defined by the Response Evaluation Criteria in Solid Tumors version 1.1. Will be estimated using 90% credible regions obtained by Jeffrey's prior method.

    Measured: Up to 4 years

  2. Overall survival

    Will be assessed using standard Kaplan-Meier methods, where estimates will be obtained with 90% confidence intervals.

    Measured: Between registration and death from any cause, assessed up to 4 years

  3. Duration of response

    Will be summarized using standard Kaplan-Meier methods, where estimates will be obtained with 90% confidence intervals.

    Measured: From the first documented objective response until the first documented disease progression or death due to any cause, assessed up to 4 years

  4. Disease control rate

    Will be defined as the proportion of patients with a best overall response of confirmed complete response, confirmed partial response, or stable disease ≥ 12 weeks. The best response status will be summarized using frequencies and relative frequencies.

    Measured: From the first dose of study drug until the first documentation of disease progression or death, assessed up to 4 years

  5. Incidence of adverse events

    Toxicities and adverse events will be assessed per Common Terminology Criteria for Adverse Events version 5.0. Will be summarized by attribution and grade using frequencies and relative frequencies.

    Measured: Up to 120 days after end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2025
  2. Study start1 Apr 2026
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07017829
Sponsor's protocol ID
I-4003224
Other IDs
NCI-2024-08947, I-4003224
Status last verified
Aug 2026
First submitted
4 Jun 2025
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anti-CFH Monoclonal Antibody GT103, Biopsy Procedure and Biospecimen Collection in people with Advanced Lung Non-Small Cell Carcinoma and Metastatic Lung Non-Small Cell Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: Between study registration and documentation of disease progression or death, whichever is observed first, assessed up to 6 months (24 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07017829.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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