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Active, Not Recruiting

NCT Number: NCT06026254

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Solid Tumor, Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Honor Health, Scottsdale, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent and mental capability to understand the informed consent
  • Currently enrolled in parent protocol IMSA101-101 and is receiving IMSA101 treatment
  • Deriving clinical benefit from study treatment, as determined by the investigator
  • Must have fulfilled all required assessments in parent protocol IMSA101-101
  • Male and female patients with reproductive potential must agree to use two forms of highly effective contraception throughout the study

Exclusion criteria

  • Permanently discontinued from IMSA101 treatment in parent protocol IMSA101-101 for any reason other than enrollment in the rollover study
  • Failure to meet the criteria specified in parent protocol IMSA101-101 for continued study treatment

Treatment and study plan

IMSA101

Drug

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

Immune checkpoint inhibitor

Drug

Administered according to product label

Other names: ICI

Primary outcomes

  1. Drug-related safety

    Time frame: 12 months

    Frequency of drug-related SAE by subject

  2. Anti-tumor effects

    Time frame: 12 months

    Tumor response based on RECIST v1.1

Sponsors and collaborators

Lead sponsor

ImmuneSensor Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 7, 2023
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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