INT230-6 for Soft Tissue Sarcoma

(INVINCIBLE-3 Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called INT230-6 for certain types of advanced soft tissue sarcoma, a cancer affecting the body's connective tissues. The main goal is to determine if INT230-6 can extend patients' lives compared to the usual treatments available in the U.S. This trial targets individuals who have tried up to two standard treatments, including one based on anthracycline, and whose cancer has continued to progress. Participants should have a type of soft tissue sarcoma that cannot be surgically removed or has metastasized. As a Phase 3 trial, this is the final step before FDA approval, offering participants access to a potentially life-extending treatment.

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.

Is there any evidence suggesting that INT230-6 is likely to be safe for humans?

Research has shown that INT230-6, the treatment being tested, has undergone previous studies. These studies have examined its safety and found promising results. For example, one study demonstrated that patients using it had a good survival rate.

Regarding safety, earlier research indicates that INT230-6 has generally been well-tolerated by patients. While every treatment can have side effects, serious adverse reactions have not been common in earlier trials. This suggests that while minor side effects might occur, the treatment is unlikely to cause major harm based on the data so far.

The treatment's progression to a later phase of testing also suggests safety. By this stage, treatments usually have substantial safety data supporting them, providing researchers with a good understanding of how well people tolerate it. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for soft tissue sarcoma, which typically involve oral or intravenous medications like Pazopanib, Trabectedin, and Eribulin, INT230-6 is administered directly into the tumor itself. This direct delivery allows for a concentrated attack on cancer cells, potentially enhancing effectiveness while minimizing systemic side effects. Researchers are excited because this method could lead to improved outcomes, offering a new way to target tumors that current treatments might miss.

What evidence suggests that INT230-6 might be an effective treatment for soft tissue sarcoma?

Research has shown that INT230-6, which participants in this trial may receive, may help treat certain advanced soft tissue sarcomas. In earlier studies, patients who received this treatment lived for an average of 21.3 months, compared to just 6.7 months for those who did not receive it. INT230-6 combines two cancer-fighting drugs, cisplatin and vinblastine, with an ingredient that helps it spread better in tumors. Administering this treatment directly into the tumor might make it more effective at killing cancer cells. These findings suggest that INT230-6 could potentially help patients live longer with this condition. ^{1 3 4 6 7}

Who Is on the Research Team?

Christian Meyer, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Premier Research

Collaborator

Citations

1. ir.intensitytherapeutics.com ir.intensitytherapeutics.com/news-events/press-releases/detail/92/intensity-therapeutics-presents-int230-6-phase-12-data-in

Intensity Therapeutics Presents INT230-6 Phase 1/2 Data ... Phase 1/2 data showed a median overall survival ("mOS") of 21.3 months versus a synthetic control of 6.7 months, an increase in T-cell ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06263231

NCT06263231 | A Study to Investigate Efficacy & Safety of ... A multicenter, randomized, phase 3 study to assess the efficacy and safety of intratumorally administered INT230-6 (SHAO, VINblastine, CIsplatin)

3. yalemedicine.org yalemedicine.org/clinical-trials/it-03-a-study-to-investigate-efficacy-and-safety-of-int230-6-compared-to-us-standard-of-care-in

A Study to Investigate Efficacy & Safety of Intratumoral ... To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS11588

A multicenter, randomized, global phase 3 study to assess ... INT230-6 is a novel formulation of cisplatin (CIS) and vinblastine (VIN) with a tissue dispersion enhancer (SHAO).

5. targetedonc.com targetedonc.com/view/phase-3-study-of-int230-6-doses-first-us-patient-with-metastatic-sarcoma

Phase 3 Study of INT230-6 Doses First US Patient With ... The first patient with metastatic sarcoma in the US has been treated with INT230-6 alone in the phase 3 INVINCIBLE-3 study.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06263231

NCT06263231 | A Study to Investigate Efficacy & Safety of ... A multicenter, randomized, phase 3 study to assess the efficacy and safety of intratumorally administered INT230-6 (SHAO, VINblastine, CIsplatin)

7. prnewswire.com prnewswire.com/news-releases/intensity-therapeutics-inc-announces-publication-of-clinical-results-of-int230-6-for-the-treatment-of-metastatic-or-refractory-cancers-in-ebiomedicine-a-lancet-discovery-science-journal-302599519.html

Intensity Therapeutics, Inc. Announces Publication of ... The paper features a comprehensive evaluation of data, including disease control rate, overall survival, immune activation, abscopal effects ...