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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Drug: IMSA101; Drug: Immune Checkpoint Inhibitor

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 Type: Interventional
• Enrollment (Estimated): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Honor Health
  • California
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug-related safety	Frequency of drug-related SAE by subject	12 months
Anti-tumor effects	Tumor response based on RECIST v1.1	12 months

Collaborators and Investigators

• Sponsor: ImmuneSensor Therapeutics Inc.
• Investigators: Study Chair: Teresa Mooneyham, ImmuneSensor Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Immune Checkpoint Inhibitors
• Other Study ID Numbers: IMSA101-101-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No