A Rollover Study for Subjects Who Completed Participation... | NCT06026254

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

NCT06026254

Sponsor

ImmuneSensor Therapeutics Inc.

Status

Active, not recruiting

Last Update Posted

Nov 18, 2024Actual

Enrollment

2Estimated

Phase

Phase 1

Conditions

Solid Tumor, Adult

Interventions

IMSA101
Immune Checkpoint Inhibitor

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2023Actual

Primary Completion Date

Sep 2025Estimated

Completion Date

Sep 2025Estimated

First Submitted Date

Aug 30, 2023

First Submission Date that Met QC Criteria

Aug 30, 2023

First Posted Date

Sep 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2024

Last Update Posted Date

Nov 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Combination Therapy	Experimental	IMSA101 + ICI	Drug: IMSA101 Drug: Immune Checkpoint Inhibitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IMSA101	Drug	Intra-tumoral administration on Days 1 and 15 of every 28-day cycle	Combination Therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Teresa Mooneyham	ImmuneSensor Therapeutics	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Honor Health		Scottsdale	Arizona	85260	United States
UC San Diego Moores Cancer Center

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000082082	Immune Checkpoint Inhibitors

Ancestor Terms

ID	Term
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D000074322	Antineoplastic Agents, Immunological

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Browse Branches

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