ITM11 Expanded Access Program | NCT07497984

Studies
ITM11 Expanded Access Program

NCT07497984

Sponsor

ITM Solucin GmbH

Status

Available

Last Update Posted

Mar 27, 2026Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Meningioma

Interventions

ITM-11

Countries

Not provided

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

Mar 2026

Overall Recruitment Status or Expanded Access Status

Available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 23, 2026

First Submission Date that Met QC Criteria

Mar 23, 2026

First Posted Date

Mar 27, 2026Actual

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

Mar 23, 2026

Last Update Posted Date

Mar 27, 2026Actual

Description Module

Brief Summary

This Expanded Access Program (EAP) is intended to provide eligible participants with access to ITM-11 prior to approval by local regulatory authorities. Program availability is subject to country eligibility. The treating physician must determine, based on the individual patient´s medical history and the program eligibility criteria, whether the potential benefits outweigh the risks of treatment with an investigational therapy.

Detailed Description

Not provided

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Individual Patients

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
ITM-11	Drug	Intravenous (IV) infusion

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Medical Affairs	Contact	609-785-5839		medical.affairs@itm-radiopharma.com

Condition Browse Module

MeSH Terms

ID	Term
D008579	Meningioma

Ancestor Terms

ID	Term
D009380	Neoplasms, Nerve Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009383	Neoplasms, Vascular Tissue

Browse Leaves

Not provided

Browse Branches

Not provided