Study on PULSAR-ICI with or without IMSA101 for Patients with Certain Types of Solid Tumors

Sponsor: ImmuneSensor Therapeutics Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05846659

Provider View

This clinical trial is testing a new treatment approach using a combination of advanced radiation therapy and immunotherapy, with or without an additional drug called IMSA101, for patients with solid tumors that have started to grow again after previous treatments.

Patient Parameters

Program Overview

The study aims to compare the safety and effectiveness of a new treatment method called PULSAR-ICI, which combines a special type of radiation therapy with immunotherapy, with or without an additional drug called IMSA101. This trial is for patients whose solid tumors have started to grow again after previous cancer treatments. The study will involve two groups of patients: one group will receive PULSAR-ICI alone, and the other group will receive PULSAR-ICI with IMSA101. The treatment will be given in cycles, and patients will be monitored for safety and how well the treatment works in controlling their cancer.

Description

In this study, patients will be divided into two groups: one group will receive the PULSAR-ICI treatment alone, and the other group will receive PULSAR-ICI combined with IMSA101. The treatment will be given in cycles, each lasting 28 days, for the first three cycles. After that, patients will continue with standard immunotherapy based on their specific treatment plan.

The study will begin with a safety phase to determine the best dose for the experimental group, followed by a randomized phase for both groups. Throughout the study, patients will be closely monitored for any side effects and how well the treatment is working against their cancer. This will include regular check-ups, lab tests, and imaging scans.

Patients will continue their assigned treatment until their cancer progresses, they experience unacceptable side effects, or the study ends. The types of tumors and treatment combinations will be determined before the first patient starts the study.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Must understand and sign a consent form.
  • Have a solid tumor that has started to grow again after previous treatment, with no more than 6 areas of cancer spread that can be treated with PULSAR.
  • Cancer must be measurable by standard criteria.
  • All cancer areas must be treatable with radiation, as decided by the doctor.
  • Must have at least one tumor that can be injected with treatment.
  • Good overall health with a performance status of 0 or 1.
  • Normal heart function as shown by an ECG.
  • Adequate blood and organ 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
    • Creatinine level below 1.5 mg/dL and creatinine clearance over 50 mL/min
    • Normal blood clotting times
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.
  • Men and women of reproductive age must agree to use two forms of effective birth control during the study.

Exclusion Criteria

  • Previous treatment with a STING agonist.
  • Previous radiation treatment to all cancer areas planned for PULSAR.
  • Recent anti-cancer therapy, except pembrolizumab and nivolumab, within 4 weeks or less than 5 half-lives before starting the study.
  • Need for treatment of the primary tumor beyond the provided immunotherapy.
  • Not fully recovered from significant side effects of previous cancer treatments.
  • History of severe immune-related side effects.
  • Untreated or unstable brain metastases.
  • Presence of mutations that can be treated with standard drugs.
  • Prolonged QT interval on an ECG.
  • Uncontrolled health conditions that could interfere with the study.
  • Pregnant or breastfeeding women.
  • The sponsor may exclude patients based on medical history, physical exams, lab results, or other criteria.

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