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

Conditions

• Advanced Lung Non-Small Cell Carcinoma
• Metastatic Lung Non-Small Cell Carcinoma
• Stage III Lung Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Anti-CFH Monoclonal Antibody GT103 — BIOLOGICAL
  Given IV
• Biopsy Procedure — PROCEDURE
  Undergo tumor biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Computed Tomography — PROCEDURE
  Undergo CT
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Pembrolizumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Apr 1, 2026

Status verified

May 2026

Primary completion

Dec 1, 2028

Completion

Dec 1, 2028

Study Design

Enrollment

28 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (GT103, pembrolizumab)
  Patients 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.

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) ]

Locations (1)

Find similar trials in Buffalo, NY

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