NCT06026254

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: ImmuneSensor Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	IMSA101	Intra-tumoral administration on Days 1 and 15 of every 28-day cycle
DRUG	Immune Checkpoint Inhibitor	Administered according to product label

Timeline

• Start date: 2023-09-15
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2023-09-07
• Last updated: 2024-11-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study