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

NCT06026254 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: IMSA101-101-R
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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).

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (2)

• Drug-related safety

  Frequency of drug-related SAE by subject

  12 months

• Anti-tumor effects

  Tumor response based on RECIST v1.1

  12 months

Study Arms (1)

Combination Therapy

EXPERIMENTAL

IMSA101 + ICI

Drug: IMSA101; Drug: Immune Checkpoint Inhibitor

Interventions

IMSA101 DRUG

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

Combination Therapy

Immune Checkpoint Inhibitor DRUG

Administered according to product label

Also known as: ICI

Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ImmuneSensor Therapeutics Inc.: lead

Study Sites (2)

Honor Health

Scottsdale, Arizona, 85260, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Interventions

Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Teresa Mooneyham

  ImmuneSensor Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 7, 2023
• Study Start: September 15, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)