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Virus Therapy

Immuno-oncology (IO) therapy for Solid Tumors

Phase 1 & 2

Waitlist Available

Research Sponsored by ImmuneSensor Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial is testing IMSA101, a new cancer drug, alone and in combination with another cancer drug. It is open to patients who have not responded to other treatments.

Eligible Conditions

Solid Tumors, Adult

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose

Secondary outcome measures

Anti-tumor Effects

Pharmacokinetic Sampling (Ph I)

Trial Design

5Treatment groups

Experimental Treatment

Group I: Ph II Monotherapy (Arm A)Experimental Treatment1 Intervention

Group II: Ph II Combination Therapy (Arm C)Experimental Treatment2 Interventions

This dose-expansion arm of 20 patients is intended to confirm the tolerability of the RP2D and identify provocative signals of IMSA101 anti-tumor activity when administered as combination therapy with non-PD-1/PD-L1-targeted immuno-oncology (IO) drugs approved by the FDA. This arm shall include a safety run-in of 5-10 patients. Tumor type and corresponding treatment combination will be identified prior to Phase IIA commencement and documented in a protocol amendment..

Group III: Ph II Combination Therapy (Arm B)Experimental Treatment2 Interventions

This dose-expansion arm of 20 patients is intended to confirm the tolerability of the RP2D and identify provocative signals of IMSA101 anti-tumor activity when administered as combination therapy with PD-1/PD-L1 targeted immune checkpoint inhibitors. This arm shall include a safety run-in of 5-10 patients. Tumor type and corresponding treatment combination will be identified prior to Phase IIA commencement and documented in a protocol amendment.

Group IV: Ph I MonotherapyExperimental Treatment1 Intervention

Dose escalation design in which administered dose levels of IMSA101 as monotherapy will be escalated stepwise in successive cohorts of 3 to 6 patients per dose group (using a standard 3+3 study design) of IMSA101 until the RP2D or maximum tolerated dose (MTD) level is identified. The first patient enrolled in each dose level must complete the first two weeks of Cycle 1 prior to enrolling the second and third patients. Dose levels to be evaluated include (although not necessarily limited to) 100 µg (representing 1/60th of the pre-clinical Highest Non-Severely Toxic Dose [HNSTD] dose), 200 µg, 400 µg, 800 µg, and 1,200 µg.

Group V: Ph I Combination TherapyExperimental Treatment2 Interventions

Ph I combination dosing of IMSA101 shall be evaluated upon satisfaction of the following criteria: A given dose level (combo dose level 1) has been confirmed as safe for monotherapy dosing (i.e. 2/6 patients experience Cycle 1 DLT). The next higher dose level (combo dose level 2) has been confirmed as safe for monotherapy dosing (i.e. 2/6 patients experience Cycle 1 DLT). The dose level (combo dose level 1) is found to demonstrate adequate IMSA101 pharmacodynamic (PD) activity based on exploratory endpoints. Eligible patients shall have demonstrated RECIST stable disease through ≥ 4 consecutive cycles of an approved PD-1/PD-L1-targeted ICI with no Grade ≥ 3 CTCAE events considered to be drug-related. Safety evaluations and dose escalation of IMSA101 administered in combination with current therapy shall proceed in a manner consistent with monotherapy escalation and shall proceed independently of monotherapy dose escalation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Immune checkpoint inhibitor (ICI)

2019

Completed Phase 2

~2260

Immuno-oncology (IO) therapy

2019

Completed Phase 2

~40

IMSA101

2019

Completed Phase 2

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ImmuneSensor Therapeutics Inc.Lead Sponsor

3 Previous Clinical Trials

99 Total Patients Enrolled

Teresa S MooneyhamStudy DirectorVice President, ImmuneSensor Therapeutics Inc.

Media Library

IMSA101 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04020185 — Phase 1 & 2

Solid Tumors Research Study Groups: Ph I Combination Therapy, Ph II Monotherapy (Arm A), Ph II Combination Therapy (Arm C), Ph II Combination Therapy (Arm B), Ph I Monotherapy

Solid Tumors Clinical Trial 2023: IMSA101 Highlights & Side Effects. Trial Name: NCT04020185 — Phase 1 & 2

IMSA101 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04020185 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current openings for people who would like to participate in this clinical trial?

"Yes, this is an active clinical trial that began on September 23rd, 2019 and was updated most recently on April 14th, 2022 according to the website clinicaltrials.gov"

Answered by AI

At how many sites is this trial being carried out?

"There are 6 study locations which can be found in cities such as Chicago, Houston and Scottsdale. It would be best to select the location nearest you to limit travel if you do decide to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy Study of IMSA101 in Refractory Malignancies

2019. "Safety and Efficacy Study of IMSA101 in Refractory Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04020185.