INT230-6 for Soft Tissue Sarcoma

(INVINCIBLE-3 Trial)

Recruiting at 16 trial locations

Overseen By Lewis H Bender, MS, MA, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Intensity Therapeutics, Inc.

Must not be taking: Immunosuppressants, Corticosteroids, Anticoagulants, others

Disqualifiers: Brain tumors, Liver disease, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 10 weeks

333 Participants Needed

Trial Summary

What is the purpose of this trial?

To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot be on certain medications like strong CYP3A4 inhibitors or those that prolong the QT interval. It's best to discuss your current medications with the trial team.

Research Team

Christian Meyer, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Adults with specific types of Soft Tissue Sarcoma (liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma) that can't be surgically removed or has spread. They should have tried an anthracycline-based treatment and up to one more therapy without success. Their tumors must be visible on scans and they need to be physically well enough for daily activities.

Inclusion Criteria

My sarcoma is one of the specified types and cannot be surgically removed.

I have had 1-2 treatments for soft tissue sarcoma and my condition worsened after.

My cancer can be measured by standard health scans.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

INT230-6 administered intratumorally every 2 weeks for up to 5 sessions or US Standard of Care until clinical deterioration or disease progression

10 weeks

5 visits (in-person)

Maintenance

Participants continue into a 22-month maintenance phase with INT230-6 injections every 12 weeks

22 months

8 visits (in-person)

Follow-up

Participants are monitored for overall survival and safety after treatment

Up to 2 years

Treatment Details

Interventions

• INT230-6

Trial Overview The trial is testing INT230-6 against the US Standard of Care treatments like Eribulin, Trabectedin, and Pazopanib in patients whose sarcomas have worsened after previous treatments. The main goal is to see if INT230-6 helps patients live longer compared to standard options.

Participant Groups

Group I: INT230-6 Monotherapy Experimental Treatment 1 Intervention

INT230-6 administered intratumorally. Participants will be dosed every 2 weeks (± 2 days) for up to a total of 5 treatment sessions (e.g., Days 1, 15, 29, 43 and 57). Once the participant has completed the treatment phase, they will continue into a 22-month maintenance phase, where investigators may inject new lesions or previously injected lesions with up to 175 mL of INT230-6 every 12 weeks (Q12W) ± 14 days. Dose volume in a session is dependent on the participants presenting tumor burden.

Group II: US Standard of Care Active Control 3 Interventions

Participants in this arm may receive any of the following depending on soft tissue sarcoma (STS) subtype and PI preference: * Pazopanib: 800 mg PO every day until clinical deterioration or disease progression * Trabectedin: 1.5 mg/m2 body surface area as 24-hour IV infusion every 3 weeks until clinical deterioration or disease progression * Eribulin: Non- European Union (EU) sites: 1.4 mg/m2 eribulin mesylate body surface area IV on Days 1 and 8 every 3 weeks until clinical deterioration or disease progression EU sites: 1.23 mg/m2 (free base) body surface area IV on Days 1 and 8 every 3 weeks until clinical deterioration or disease progression

INT230-6 is already approved in United States, Canada, European Union for the following indications:

Approved in United States as INT230-6 for:

• Soft tissue sarcomas (under investigation)

Approved in Canada as INT230-6 for:

• Soft tissue sarcomas (under investigation)

Approved in European Union as INT230-6 for:

• Soft tissue sarcomas (under investigation)

Who Is Running the Clinical Trial?

Intensity Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

530+

Premier Research Group plc

Industry Sponsor

Trials

65

Recruited

74,200+

John Ratliff

Premier Research Group plc

Chief Executive Officer since 2024

MBA

Dr. Milena Kanova-Petrova

Premier Research Group plc

Chief Medical Officer since 2024

MD