Study on PULSAR-ICI with or without IMSA101 for Patients with Limited Metastatic Lung and Kidney Cancer

Sponsor: ImmuneSensor Therapeutics Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05846646

Provider View

This clinical trial is testing a new combination of treatments for patients with a specific type of lung or kidney cancer that has spread to a few areas. The study compares the effects of a specialized radiation therapy combined with immunotherapy, with or without an additional drug called IMSA101.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a new treatment approach for patients with non-small cell lung cancer (NSCLC) or renal cell carcinoma (RCC) that has spread to a limited number of sites. The treatment involves a combination of personalized radiation therapy and immunotherapy, with some patients also receiving an additional drug, IMSA101. The trial will monitor how well the treatments work and their safety over several cycles, each lasting 28 days.

Description

In this study, patients will be divided into two groups: one group will receive a combination of personalized radiation therapy and immunotherapy (PULSAR-ICI), while the other group will receive the same treatment with an additional drug called IMSA101. Each group will have 20 patients.

The treatment will be given in cycles, with each cycle lasting 28 days. Patients will receive the combination treatment for the first three cycles, after which they will continue with standard immunotherapy alone. The study will start with a safety phase to ensure the treatment is safe, followed by a randomized phase where patients are assigned to one of the two groups.

Throughout the study, patients will be closely monitored for any side effects and how well the treatment is working. This will include regular health checks, lab tests, and imaging scans to assess the cancer's response to the treatment. Patients will continue with the study treatment until their cancer progresses, they experience unacceptable side effects, or the study ends.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Must understand and sign a consent form.
  • Diagnosed with non-small cell lung cancer (NSCLC) or renal cell carcinoma (RCC) with up to 6 areas of cancer spread.
  • Cancer must be measurable by standard criteria.
  • All cancer areas must be treatable with radiation.
  • Must have at least one tumor suitable for injection.
  • Good overall health with a performance status of 0 or 1.
  • Normal heart function as shown by an ECG.
  • Adequate organ and bone marrow function, including:
    • Neutrophil count over 1,500 cells/μL
    • Platelet count over 50,000 cells/μL
    • Bilirubin level within 1.5 times the normal limit
    • Liver enzymes (AST/ALT) within 2.5 times the normal limit, or 5 times if liver metastases are present
    • Serum creatinine below 1.5 mg/dL and creatinine clearance over 50 mL/min
    • Normal blood clotting times
  • Women of childbearing age must have a negative pregnancy test and use effective birth control.
  • Men and women with reproductive potential must agree to use two forms of effective contraception during the study.

Exclusion Criteria

  • Previous progression on PD-L1 or PD-1 immunotherapy.
  • Prior use of STING agonist.
  • Previous radiation to the areas planned for PULSAR treatment.
  • Recent anti-cancer therapy, except pembrolizumab and nivolumab, within 4 weeks or less than 5 half-lives of the first study dose.
  • Need for treatment beyond the provided immunotherapy.
  • Unresolved side effects from previous cancer treatments.
  • History of severe immune-related side effects.
  • Presence of mutations eligible for standard targeted therapy.
  • Brain metastases.
  • Abnormal heart rhythm (QTc interval over 470).
  • Uncontrolled health conditions that could interfere with the study.
  • Pregnant or breastfeeding women.
  • The sponsor may exclude patients based on medical history or other criteria.

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