Solid Tumor, AdultPhase 1NCT06026254
A Rollover Study for Subjects Who Completed Participation in IMSA101-101 Trial
A Phase 1 study testing IMSA101 and Immune Checkpoint Inhibitor in people with Solid Tumor, Adult, run by ImmuneSensor Therapeutics Inc. at 2 sites in United States.
Trial summary
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). 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 and Immune Checkpoint Inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2023to Sep 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Currently enrolled in parent protocol IMSA101-101 and is receiving IMSA101 treatment
- Deriving clinical benefit from study treatment, as determined by the investigator
- Must have fulfilled all required assessments in parent protocol IMSA101-101
- Male and female patients with reproductive potential must agree to use two forms of highly effective contraception throughout the study
Who cannot join
- Permanently discontinued from IMSA101 treatment in parent protocol IMSA101-101 for any reason other than enrollment in the rollover study
- Failure to meet the criteria specified in parent protocol IMSA101-101 for continued study treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Honor Health
Scottsdale, Arizona, 85260
About this study
Official title: 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
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).
Read the detailed description
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.
- Conditions
- Solid Tumor, Adult
- Being tested
- IMSA101, Immune Checkpoint Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMSA101Drug
Intra-tumoral administration on Days 1 and 15 of every 28-day cycle
Immune Checkpoint InhibitorDrug
Also called ICI
Administered according to product label
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy | Experimental | IMSA101 + ICI Receives: Drug: IMSA101; Drug: Immune Checkpoint Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug-related safety
Frequency of drug-related SAE by subject
Measured: 12 months
Anti-tumor effects
Tumor response based on RECIST v1.1
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start15 Sep 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmuneSensor Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teresa Mooneyham, Study chair, ImmuneSensor Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026254
- Sponsor's protocol ID
- IMSA101-101-R
- Status last verified
- Nov 2024
- First submitted
- 30 Aug 2023
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06026254
- Acronym / sponsor ID
- IMSA101-101-R
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- ImmuneSensor Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy | Experimental | Drug: IMSA101, Drug: Immune Checkpoint InhibitorIMSA101 + ICI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent and mental capability to understand the informed consent
- Currently enrolled in parent protocol IMSA101-101 and is receiving IMSA101 treatment
- Deriving clinical benefit from study treatment, as determined by the investigator
- Must have fulfilled all required assessments in parent protocol IMSA101-101
- Male and female patients with reproductive potential must agree to use two forms of highly effective contraception throughout the study
Key exclusion criteria (2 listed)
- Permanently discontinued from IMSA101 treatment in parent protocol IMSA101-101 for any reason other than enrollment in the rollover study
- Failure to meet the criteria specified in parent protocol IMSA101-101 for continued study treatment
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 |
|---|---|---|
| IMSA101Intra-tumoral administration on Days 1 and 15 of every 28-day cycle | Drug | Combination Therapy |
| Immune Checkpoint InhibitorAlso: ICIAdministered according to product label | Drug | Combination Therapy |
Primary outcome
Drug-related safety
Time frame: 12 months
Frequency of drug-related SAE by subject
Anti-tumor effects
Time frame: 12 months
Tumor response based on RECIST v1.1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- 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 Mooneyham study chair
ImmuneSensor Therapeutics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMSA101 and Immune Checkpoint Inhibitor in people with Solid Tumor, Adult, run by ImmuneSensor Therapeutics Inc. at 2 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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Drug-related safety (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2024.