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Virus Therapy

Safety and Efficacy Study of IMSA101 in Refractory Malignancies

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

No Placebo-Only Group

Summary

This trial tests a new treatment called IMSA101, which is injected directly into tumors. It is sometimes used with another drug that helps the immune system fight cancer. The study focuses on patients whose tumors can be accessed for these injections. The goal is to see if this approach can effectively shrink tumors and improve patient outcomes.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose

Secondary study objectives

Anti-tumor Effects

Pharmacokinetic Sampling (Ph I)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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