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Safety and Efficacy Study of IMSA101 in Refractory Malignancies

NCT04020185 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-11

Study results available
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Summary

Open-label, dose escalation (Phase I) and dose expansion (Phase IIA) study of patients receiving intra-tumoral IMSA101 alone or in combination with an immune checkpoint inhibitor (ICI) (Phase I and II)

Conditions

  • Solid Tumor, Adult

Interventions

DRUG

IMSA101

IMSA101 administered by intra-tumoral (IT) injection on Day 1 of Weeks 1, 2, and 3 for Cycle 1 and on Day 1 of Weeks 1 and 3 for all subsequent cycles.

DRUG

Immune checkpoint inhibitor (ICI)

Administered according to product label

DRUG

Immuno-oncology (IO) therapy

Administered according to product label

Sponsors & Collaborators

  • ImmuneSensor Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Teresa S Mooneyham · Vice President, ImmuneSensor Therapeutics Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-23
Primary Completion
2023-09-15
Completion
2023-09-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04020185 on ClinicalTrials.gov