Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Pembrolizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Intra-tumoral administration once weekly for the first three weeks of Cycle 1 (Days 1, 8 and 15) and then on Day 1 of Cycles 2 and 3.

IMSA101

1st infusion on Cycle 1 Day 2, and then thereafter as per product label.

Immune checkpoint inhibitor

PULSAR

Patrick Widhelm

Jenny P Sanchez

Kat Irenze, RN

Percy Lee, MD

Sarah Chevalier, RN

Andrew Zeng

Jason Ye, MD

Talia Oughourlian

Drew Moghanaki, MD

Elise Catherine Lemp

Devalingam Mahalingam, MB BCh, BAO, PhD

Caitlyn Kwan

Mai Anh Huynh, MD

Jennifer Traber

Greg Vlacich, MD

Adel Zakharia

Alla Ahmed

Nitin Ohri, MD

Megan Tyler

Aryavarta Kumar, MD

Ahmed Gul

Sarah Neufelf

Mona Arbab, MD

Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) combined with immune checkpoint inhibitor (ICI) immunotherapy (PULSAR-ICI) + IMSA101 and PULSAR-ICI alone in patients with oligoprogressive solid tumor malignancies after prior anti-cancer therapy.

Patients shall be enrolled in 2 treatment arms as follows:

1. 15 patients in the control arm (PULSAR-ICI alone)
2. 30 patients in the experimental arm (PULSAR-ICI + IMSA101)

PULSAR-ICI with or without IMSA101 treatment will be administered to the patients in Cycles 1, 2, and 3, and thereafter only standard of care ICI monotherapy will be administered to all patients. Each treatment cycle will be 28 days in duration for Cycles 1, 2 and 3, then per standard of care monotherapy thereafter based on the product labels of the prescribed ICI.

The study will start with a safety run-in portion at 2 dose levels for the experimental arm, followed by a randomized portion for both treatment arms. The safety run-in shall employ a 3+3 safety run-in component.

All patients will be followed throughout the study for drug tolerability and safety by collecting clinical and laboratory data, including adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria, SAEs, concomitant medications, and vital signs.

All patients will be assessed for anti-tumor efficacy at screening, prior to the end of Cycle 3, and at 8-week intervals thereafter based on radiographic assessments (all outcome measures per RECIST Version 1.1 and iRECIST).

Tumor types and the corresponding treatment combinations to be evaluated will be identified prior to the first patient enrolled.

All patients will continue to receive their assigned treatment throughout the study until the occurrence of disease progression (based on iRECIST), death, or other unacceptable treatment-related toxicity, or until the study is closed by the sponsor.

Study of PULSAR-ICI +/- IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies

Phase 2 Randomized Clinical Trial Comparing the Safety and Efficacy of PULSAR-Integrated Radiotherapy + Pembrolizumab or Nivolumab Administered With or Without STING-Agonist IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies

Occurrence of treatment-related adverse events and SAEs

Progression-free at 8-week intervals from 6 months to 22 months

Overall response rate, duration of response, progression-free survival

ImmuneSensor Therapeutics Inc.

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Renal Cell

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

1st infusion on Cycle 1 Day 2, and then thereafter as per product label

Juan Miranda

Maggie Thomas, RN, BSN

Krishna Reddy, MD

Manideepika Katta

Matthew Deek, MD

Alena Turner

Benjamin Maughan, MD, Pharm D

Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) combined with immune checkpoint inhibitor (ICI) immunotherapy (PULSAR-ICI) + IMSA101 and PULSAR-ICI alone in patients with NSCLC or RCC

Patients shall be enrolled in 2 treatment arms as follows:

1. 20 patients in the control arm (PULSAR-ICI alone)
2. 20 patients in the experimental arm (PULSAR-ICI + IMSA101)

Patients will be stratified by histology (NSCLC and RCC) in the randomized portion.

PULSAR-ICI with or without IMSA101 treatment will be administered to the patients in Cycles 1, 2, and 3, and thereafter only standard of care ICI monotherapy will be administered to all patients. Each treatment cycle will be 28 days in duration for Cycles 1, 2 and 3, then per standard of care monotherapy thereafter based on the product labels of the prescribed ICI.

The study will start with a safety run-in portion at 2 dose levels for the experimental arm, followed by a randomized portion for both treatment arms. The safety run-in shall employ a 3+3 safety run-in component.

All patients will be followed throughout the study for drug tolerability and safety by collecting clinical and laboratory data, including adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria, SAEs, concomitant medications, and vital signs.

All patients will be assessed for anti-tumor efficacy at screening, prior to the end of Cycle 3, and at 8-week intervals thereafter based on radiographic assessments (all outcome measures per RECIST Version 1.1 and iRECIST).

All patients will continue to receive their assigned treatment throughout the study until the occurrence of disease progression (based on iRECIST), death, or other unacceptable treatment-related toxicity, or until the study is closed by the sponsor.

Study of PULSAR-ICI +/- IMSA101 in Patients With Oligometastatic NSCLC and RCC

Phase 2 Randomized Clinical Trial Comparing the Safety and Efficacy of PULSAR-Integrated Radiotherapy + Pembrolizumab or Nivolumab Administered With or Without STING-Agonist IMSA101 in Patients With Oligometastatic NSCLC and RCC

Occurrence of treatment-related adverse events

Patient reported outcome on FACT-G questionnaire

* 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.

* 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.

* 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 monotherapy
* Tumor type to be evaluated will be identified prior to Phase IIA commencement and will be documented in a protocol amendment.

* 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.

* 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..

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.

Immune checkpoint inhibitor (ICI)

Immuno-oncology (IO) therapy

Teresa S Mooneyham

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)

This is an open-label, dose escalation (Phase I), and dose expansion (Phase IIA) study designed to evaluate safety and efficacy of IMSA101 alone or in combination with an ICI (Phase I and II). Therefore, the study will be conducted in 2 phases. The dose of IMSA101 in Phase IIA will be based on the monotherapy and combination Recommended Phase 2 Doses (RP2Ds) from Phase I.

The following methodology applies to all patients (unless otherwise indicated):

* Pre-treatment screening radiographic tumor assessments will be collected within 30 days prior to initial dose for all patients. Photographic assessments for cutaneously-accessible lesions will be performed as detailed in a separate photography manual.
* Treatment cycles will be 28 days in duration with lesions injected weekly on Day 1 for the first three weeks of Cycle 1 and then every 2 weeks during cycles 2 and beyond.
* A single pre-defined lesion/lesion site (longest diameter ≥ 10 mm and ≤ 35 mm) shall be injected throughout study duration, if possible. Where the original injection site is considered by the investigator to become inaccessible, a second lesion/lesion site shall be selected as a replacement and this shall be used henceforth so long as it is considered accessible. Subsequent injection sites shall be replaced when they are considered inaccessible.
* Where no remaining accessible lesions are present and where benefit of IMSA101 therapy is, in the opinion of the investigator, being derived by the patient, continued injections of IMSA101 into the vicinity of an inaccessible lesion or, in the case that a lesion can no longer be radiographically visualized, into the last known location of the non-visible lesion shall be allowed.
* Patients will be admitted to the hospital for observation overnight following IT injection with IMSA101 on Day 1 of Cycle 1. Patients will be followed throughout the study for drug tolerability and safety by collection of clinical and laboratory data, including information on adverse events (AEs) using CTCAE v5.0 criteria, serious adverse events (SAEs), DLTs, concomitant medications, vital signs, and electrocardiograms (ECGs).
* Patients will be assessed for anti-tumor efficacy based on radiographic assessments and if applicable, photographic tumor assessments, and analysis of Objective Response Rate (ORR), Time to Progression (TTP), and Progression Free Survival (PFS) using RECIST criteria (Appendix 13.2) at screening and the end (≤ 7 days) of even numbered cycles (Cycle 2, Cycle 4, etc.) after the first dosing.

Phase I includes a monotherapy arm and an immune checkpoint inhibitor (ICI) combination therapy arm Phase II includes three arms, Arm A monotherapy, Arm B immuno-oncology (IO) combination therapy, Arm C IO combination therapy

Safety and Efficacy Study of IMSA101 in Refractory Malignancies

Phase I/IIA Safety and Efficacy Study of IMSA101 in Patients With Advanced Treatment-Refractory Malignancies

Number of adverse events and dose limiting toxicities per CTCAE v 5.0

Area under the curve minimum plasma concentration

Tumor response, based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1), in patients evaluable for response.

Duration of response (DOR), based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1), in patients evaluable for response.

Time to tumor progression (TTP), based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1), in patients evaluable for response.

Progression free survival (PFS), based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1), in patients evaluable for response.

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

Immune Checkpoint Inhibitor

Teresa Mooneyham

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).

The following methodology applies to all patients:

* Treatment cycles will be 28 days in duration with lesions injected every 2 weeks. IMSA101 dose level will remain the same as at the time of the rollover from parent protocol.
* ICI dose level and treatment regimen will remain the same as at the time of the rollover from parent protocol, following the labeled instructions.
* The same single pre-defined lesion/lesion site (longest diameter ≥ 10 mm and ≤ 50 mm) shall be injected throughout study duration, if possible. Where the original injection site is considered by the investigator to become inaccessible, a second lesion/lesion site shall be selected as a replacement and this shall be used henceforth so long as it is considered accessible. Subsequent injection sites shall be replaced when they are considered inaccessible.
* Where no remaining accessible lesions are present and where benefit of IMSA101 therapy is, in the opinion of the investigator, being derived by the patient, continued injections of IMSA101 into the vicinity of an inaccessible lesion or, in the case that a lesion can no longer be radiographically visualized, into the last known location of the non-visible lesion shall be allowed.

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

Rollover Study to Continue IMSA101 Treatments in Patients With Advanced Treatment-Refractory Malignancies Previously Enrolled in the Phase I/IIA Safety and Efficacy Study of IMSA101

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of PULSAR-ICI +/- IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies	NCT05846659	Oligoprogressiv...	IMSA101 Immune checkpoi... PULSAR	18 Years -	ImmuneSensor Therapeutics Inc.
Study of PULSAR-ICI +/- IMSA101 in Patients With Oligometastatic NSCLC and RCC	NCT05846646	Oligometastatic...	IMSA101 Immune checkpoi... PULSAR	18 Years -	ImmuneSensor Therapeutics Inc.
Safety and Efficacy Study of IMSA101 in Refractory Malignancies	NCT04020185	Solid Tumor, Ad...	IMSA101 Immune checkpoi... Immuno-oncology...	18 Years -	ImmuneSensor Therapeutics Inc.
A Rollover Study for Subjects Who Completed Participation in IMSA101-101 Trial	NCT06026254	Solid Tumor, Ad...	IMSA101 Immune Checkpoi...	18 Years -	ImmuneSensor Therapeutics Inc.
Study of PULSAR-ICI +/- IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies	NCT05846659	Oligoprogressiv...	IMSA101 Immune checkpoi... PULSAR	18 Years -	ImmuneSensor Therapeutics Inc.
Safety and Efficacy Study of IMSA101 in Refractory Malignancies	NCT04020185	Solid Tumor, Ad...	IMSA101 Immune checkpoi... Immuno-oncology...	18 Years -	ImmuneSensor Therapeutics Inc.

Spots Global Cancer Trial Database for imsa101

Every month we try and update this database with for imsa101 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for imsa101

Every month we try and update this database with for imsa101 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for imsa101 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.