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A Rollover Study for Subjects Who Completed Participation in IMSA101-101 Trial

Sponsor
ImmuneSensor Therapeutics Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06026254
Collaborator
(none)
2
Enrollment
1
Arm
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a rollover study from parent protocol IMSA101-101 for adult patients with advanced malignancies that were previously receiving IMSA101 and who would continue to receive benefit with study treatment of IMSA101 in combination with an immune checkpoint inhibitor (ICI).

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

The following methodology applies to all patients:

  • Treatment cycles will be 28 days in duration with lesions injected every 2 weeks. IMSA101 dose level will remain the same as at the time of the rollover from parent protocol.

  • ICI dose level and treatment regimen will remain the same as at the time of the rollover from parent protocol, following the labeled instructions.

  • The same single pre-defined lesion/lesion site (longest diameter ≥ 10 mm and ≤ 50 mm) shall be injected throughout study duration, if possible. Where the original injection site is considered by the investigator to become inaccessible, a second lesion/lesion site shall be selected as a replacement and this shall be used henceforth so long as it is considered accessible. Subsequent injection sites shall be replaced when they are considered inaccessible.

  • Where no remaining accessible lesions are present and where benefit of IMSA101 therapy is, in the opinion of the investigator, being derived by the patient, continued injections of IMSA101 into the vicinity of an inaccessible lesion or, in the case that a lesion can no longer be radiographically visualized, into the last known location of the non-visible lesion shall be allowed.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Rollover Study to Continue IMSA101 Treatments in Patients With Advanced Treatment-Refractory Malignancies Previously Enrolled in the Phase I/IIA Safety and Efficacy Study of IMSA101
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Combination Therapy

IMSA101 + ICI

Drug: IMSA101
Intra-tumoral administration on Days 1 and 15 of every 28-day cycle

Drug: Immune Checkpoint Inhibitor
Administered according to product label
Other Names:
  • ICI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Drug-related safety [12 months]

      Frequency of drug-related SAE by subject

    2. Anti-tumor effects [12 months]

      Tumor response based on RECIST v1.1

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Signed informed consent and mental capability to understand the informed consent

    2. Currently enrolled in parent protocol IMSA101-101 and is receiving IMSA101 treatment

    3. Deriving clinical benefit from study treatment, as determined by the investigator

    4. Must have fulfilled all required assessments in parent protocol IMSA101-101

    5. Male and female patients with reproductive potential must agree to use two forms of highly effective contraception throughout the study

    Exclusion Criteria:

    1. Permanently discontinued from IMSA101 treatment in parent protocol IMSA101-101 for any reason other than enrollment in the rollover study

    2. Failure to meet the criteria specified in parent protocol IMSA101-101 for continued study treatment

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • ImmuneSensor Therapeutics Inc.

    Investigators

    • Study Chair: Teresa Mooneyham, ImmuneSensor Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ImmuneSensor Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT06026254
    Other Study ID Numbers:
    • IMSA101-101-R
    First Posted:
    Sep 7, 2023
    Last Update Posted:
    Sep 8, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Immune Checkpoint Inhibitors

    Study Results

    No Results Posted as of Sep 8, 2023