Safety and Efficacy Study of IMSA101 in Refractory Malignancies

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: ImmuneSensor Therapeutics Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Teresa S Mooneyham

Principal Investigator

Vice President, ImmuneSensor Therapeutics Inc.

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically documented locally advanced or metastatic solid tumor malignancies refractory to or otherwise ineligible for treatment with standard-of-care agents/regimens, including but not limited to: Malignant melanoma, Hormone receptor negative breast cancer, Gastro-esophageal cancer, Non-small cell lung cancer, Head and neck cancer, Hepatoma, Renal cell carcinoma

Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

Evaluable or measurable disease as follows: A minimum of 3 RECIST-evaluable lesions: one that is suitable for injection and biopsied; one non-injected that will be biopsied for abscopal effect; and one measurable lesion that will be followed for response only. Injectable tumors shall be accessed by intralesional (cutaneous) or percutaneous injection only, including those lesions that are visible, palpable, or detectable by standard radiographic or ultrasound methods. Neither surgical procedures nor endoscopically-guided injections including those to endobronchial, endoluminal, or endosinusial spaces shall be allowed. While no anatomic locations are required or disallowed, lesions selected for intratumoral injection must, in the opinion of the investigator: Not be immediately adjacent to blood vasculature or other physiologic landmarks in such a way that will accrue undue safety risk to the patient, Have longest diameter ≥ 10 mm and ≤ 50 mm, Be fully efficacy evaluable per RECIST v1.1 criteria

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Exclusion Criteria

Anti-cancer therapy within 4 weeks or < 5 half-lives of the first dose of study drug.

Failure to recover to Grade 1 or less from clinically significant AEs due to prior anti-cancer therapy.

Known untreated brain metastases or treated brain metastases that have not been stable (scan showing no worsening of central nervous system (CNS) lesion[s] and no requirement of corticosteroids) ≥ 4 weeks prior to study enrollment

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Treatment Details

Interventions

Immune checkpoint inhibitor (ICI) (Checkpoint Inhibitor)
IMSA101 (Virus Therapy)

Participant Groups

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.