Solid Tumor, AdultPhase 1/2NCT04020185
Safety and Efficacy Study of IMSA101 in Refractory Malignancies
A Phase 1/2 study testing IMSA101, Immune checkpoint inhibitor (ICI) and Immuno-oncology (IO) therapy in people with Solid Tumor, Adult, run by ImmuneSensor Therapeutics Inc. at 6 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- IMSA101, Immune checkpoint inhibitor (ICI) and Immuno-oncology (IO) therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesUnited States
- Study dates
- 23 Sep 2019to 15 Sep 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent and mental capability to understand the informed consent
- Male or female patients > 18 years of age
- 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
Show all 29Show fewer
- 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
- Life expectancy > 3 months (Phase I) and > 6 months (Phase IIA)
- ECG without evidence of clinically meaningful conduction abnormalities or active ischemia as determined by the investigator
- Acceptable organ and marrow function as defined below:
- Absolute neutrophil count > 1,500 cells/μL
- Platelets > 50,000 cells/μL
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
- Aspartate aminotransferase (AST)/alanine transaminase (ALT) ≤ 2.5 times ULN. If liver metastases are present, AST/ALT < 5 times ULN
- Serum creatinine < 1.5 mg/dL and a measured creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula
- Prothrombin time (PT)/partial thromboplastin time (PTT) ≤ 1.5 times ULN
- Women of child-bearing potential (defined as a female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months with an appropriate clinical profile at the appropriate age, e.g., greater than 45 years) must have a negative serum pregnancy test prior to first dose of study drug
- Male and female patients with reproductive potential must agree to use two forms of highly effective contraception throughout the study
- Phase I combination only: Demonstrated RECIST stable disease through ≥ 4 consecutive cycles of an approved PD-1 or PD-L1 targeted ICI with no Grade ≥ 3 CTCAE events considered by the investigator to be drug-related.
Who cannot join
- 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
- Baseline prolongation of QT/QTc interval (QTc interval > 470)
- Uncontrolled intercurrent illness (including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations) that in opinion of the investigator would limit compliance with study requirements
- Women who are pregnant or breastfeeding
- Phase I combination only: Prior tumor progression through PD-1 or PD-L1 targeted ICI therapy.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Northwestern University
Chicago, Illinois, 60611
UT Southwestern
Dallas, Texas, 75390
MD Anderson Cancer Center
Houston, Texas, 77030
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Atlantic Health System/Morristown Medical Center
Morristown, New Jersey, 07962
Honor Health
Scottsdale, Arizona, 85260
About this study
Official title: Phase I/IIA Safety and Efficacy Study of IMSA101 in Patients With Advanced Treatment-Refractory Malignancies
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)
Read the detailed description
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.
- Conditions
- Solid Tumor, Adult
- Being tested
- IMSA101, Immune checkpoint inhibitor (ICI), Immuno-oncology (IO) therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMSA101Drug
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)Drug
Administered according to product label
Immuno-oncology (IO) therapyDrug
Administered according to product label
| Study group | Role | What they receive |
|---|---|---|
| Ph I Monotherapy | Experimental | * 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. Receives: Drug: IMSA101 |
| Ph I Combination Therapy | Experimental | * 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. Receives: Drug: IMSA101; Drug: Immune checkpoint inhibitor (ICI) |
| Ph II Monotherapy (Arm A) | Experimental | * 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. Receives: Drug: IMSA101 |
| Ph II Combination Therapy (Arm B) | Experimental | * 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. Receives: Drug: IMSA101; Drug: Immune checkpoint inhibitor (ICI) |
| Ph II Combination Therapy (Arm C) | Experimental | * 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.. Receives: Drug: IMSA101; Drug: Immuno-oncology (IO) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicities
Highest dose level of IMSA101 at which no more than 1 out of 6 patients experienced a dose limiting toxicity (DLT) during the first cycle (28 days) of therapy.
Measured: Cycle 1 (28 days) of therapy
Secondary outcomes (1)
Best Overall Response
The sum of number of patients with best overall response (complete response, partial response, stable disease or progressive disease) as per RECIST v1.1 until End of Treatment. Tumor response was evaluated at the end of each even numbered cycle (eg. Cycle 2, Cycle 4, etc.) until End of Treatment.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start23 Sep 2019
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmuneSensor Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teresa S Mooneyham, Study director, Vice President, ImmuneSensor Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020185
- Sponsor's protocol ID
- IMSA101-101
- Status last verified
- Dec 2024
- First submitted
- 11 Jul 2019
- Last updated
- 11 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacoby J, Mahalingam D, Alistar A, Garmey E, Kazmi S, Mooneyham T, Sun L, Yap TA, Vu P, Moser J. Phase 1 first-in-human dose-escalation study of IMSA101, a novel cyclic di-nucleotide STING agonist, for patients with advanced solid tumor malignancies. J Immunother Cancer. 2025 Jun 18;13(6):e011572. doi: 10.1136/jitc-2025-011572.
PubMed 40533265
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIA Safety and Efficacy Study of IMSA101 in Patients With Advanced Treatment-Refractory Malignancies
- ClinicalTrials.gov ID
- NCT04020185
- Acronym / sponsor ID
- IMSA101-101
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ImmuneSensor Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Posted 11 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Ph I Monotherapy | Experimental | Drug: IMSA101* 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 Therapy | Experimental | Drug: IMSA101, Drug: Immune checkpoint inhibitor (ICI)* 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. |
| Ph II Monotherapy (Arm A) | Experimental | Drug: IMSA101* 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. |
| Ph II Combination Therapy (Arm B) | Experimental | Drug: IMSA101, Drug: Immune checkpoint inhibitor (ICI)* 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. |
| Ph II Combination Therapy (Arm C) | Experimental | Drug: IMSA101, Drug: Immuno-oncology (IO) therapy* 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.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Signed informed consent and mental capability to understand the informed consent
- Male or female patients > 18 years of age
- 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:
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Evaluable or measurable disease as follows:
Key exclusion criteria (7 listed)
- 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
- Baseline prolongation of QT/QTc interval (QTc interval > 470)
- Uncontrolled intercurrent illness (including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations) that in opinion of the investigator would limit compliance with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMSA101IMSA101 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 | Ph I Combination Therapy, Ph I Monotherapy, Ph II Combination Therapy (Arm B), Ph II Combination Therapy (Arm C), Ph II Monotherapy (Arm A) |
| Immune checkpoint inhibitor (ICI)Administered according to product label | Drug | Ph I Combination Therapy, Ph II Combination Therapy (Arm B) |
| Immuno-oncology (IO) therapyAdministered according to product label | Drug | Ph II Combination Therapy (Arm C) |
Primary outcome
Number of Participants With Dose-Limiting Toxicities
Time frame: Cycle 1 (28 days) of therapy
Highest dose level of IMSA101 at which no more than 1 out of 6 patients experienced a dose limiting toxicity (DLT) during the first cycle (28 days) of therapy.
1 secondary outcome
Best Overall Response
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40533265Jacoby J, Mahalingam D, Alistar A, Garmey E, Kazmi S, Mooneyham T, Sun L, Yap TA, Vu P, Moser J. Phase 1 first-in-human dose-escalation study of IMSA101, a novel cyclic di-nucleotide STING agonist, for patients with advanced solid tumor malignancies. J Immunother Cancer. 2025 Jun 18;13(6):e011572. doi: 10.1136/jitc-2025-011572.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa S Mooneyham study director
Vice President, ImmuneSensor Therapeutics Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMSA101, Immune checkpoint inhibitor (ICI) and Immuno-oncology (IO) therapy in people with Solid Tumor, Adult, run by ImmuneSensor Therapeutics Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-Limiting Toxicities (time frame: Cycle 1 (28 days) of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04020185, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.