Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06263231 | A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3) | PHASE3 | ACTIVE NOT_RECRUITING | 333 | — | — | Jun 28, 2024 | Dec 1, 2028 | Jul 29, 2025 | 17 | United States, Canada +3 |
To compare OS for INT230-6 vs 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.
| Arm | Type | Description |
|---|---|---|
| INT230-6 Monotherapy | EXPERIMENTAL | 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. |
| US Standard of Care | ACTIVE_COMPARATOR | 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 |
| Name | Type | Description |
|---|---|---|
| INT230-6 | DRUG | INT230-6 is a fixed combination of cisplatin, vinblastine and SHAO. |
| Eribulin | DRUG | Eribulin IV |
| Trabectedin | DRUG | Trabectedin infusion |
| Pazopanib | DRUG | Pazopanib pill |
Inclusion Criteria: 1. Participant is of any sex and must be ≥ 18 years old and provide written informed consent to participate in the study. Type of Participant and Disease Characteristics 2. Histologically proven, unresectable, locally advanced, or metastatic Soft Tissue Sarcoma (STS) only of...