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INT230-6 · 2 trials · 12 indications
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.
The primary objective is to assess the safety and tolerability of single and multiple intratumoral doses of INT230-6 in subjects with advanced or recurrent malignancies. This will be assessed by the rate of ≥ grade 3 AE's attributed to INT230-6 and not the underlying disease. NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 (least severe) to 5 (most severe)) All recorded adverse events will be listed and tabulated by system organ class, preferred term, and dose and coded according to the most current version of MedDRA. The incidence of adverse events will be tabulated and reviewed for potential significance and clinical importance. Adverse Events will be summarized for all reported data and by study period: a) up to and including 28 days post last dose of initial treatment, and b) from first dose of re-initiation of treatment, for subjects who re-initiate study therapy while in follow-up, up to 28 days post-dose of the last re-treatment dose.
| 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 |
| Monotherapy With >=40% Total Tumor Burden Dosed (Cohorts A1/B1/EA/EC/EC2/EC3) | EXPERIMENTAL | Dosing: \>=40% Total Tumor Burden A1:INT230-6 injections into only superficial tumors, low starting dose, low concentration per tumor. B1:INT230-6 injections into deep tumors, low starting dose, low drug concentration per tumor Dosing schedule for A1 and B1 is every 28 days for 5 sessions EA:INT230-6 injections into superficial tumors, medium starting dose, low drug concentration per tumor EC:INT230-6 injections into superficial or deep tumors, moderately high starting dose, high drug concentration per tumor EC2:INT230-6 injections into superficial or deep tumors, high starting dose, moderate drug concentration per tumor, higher number of tumors to be treated per session than EC. EC3:INT230-6 injections at fixed maximal dose into superficial or deep tumors, unlimited number of tumors to be treated per session with retreatment once every 9 weeks for two years. Dosing schedule for EA, EC, EC2 and EC3 is every 2 weeks for 5 sessions Completed Cohorts |
| Monotherapy With <40% Total Tumor Burden Dosed (Cohorts A1/B1/EA/EC/EC2/EC3) | EXPERIMENTAL | Dosing: \<40% Total Tumor Burden A1:INT230-6 injections into only superficial tumors, low starting dose, low concentration per tumor. B1:INT230-6 injections into deep tumors, low starting dose, low drug concentration per tumor Dosing schedule for A1 and B1 is every 28 days for 5 sessions EA:INT230-6 injections into superficial tumors, medium starting dose, low drug concentration per tumor EC:INT230-6 injections into superficial or deep tumors, moderately high starting dose, high drug concentration per tumor EC2:INT230-6 injections into superficial or deep tumors, high starting dose, moderate drug concentration per tumor, higher number of tumors to be treated per session than EC. EC3:INT230-6 injections at fixed maximal dose into superficial or deep tumors, unlimited number of tumors to be treated per session with retreatment once every 9 weeks for two years. Dosing schedule for EA, EC, EC2 and EC3 is every 2 weeks for 5 sessions Completed Cohorts |
| INT230-6 Combined With Pembrolizumab (Cohorts DEC/DEC2) | EXPERIMENTAL | DEC: INT230-6 injections every 2 weeks for 5 sessions with the possibility for INT230-6 retreatment into superficial tumors, with addition of anti-PD-1 antibody KEYTRUDA® (pembrolizumab) dosed concurrently starting at Day 1 every 3 weeks for two years for selected cancer types. Completed Cohort DEC2:INT230-6 per the dosing of cohort EC3 combined with KEYTRUDA® (pembrolizumab) dosed per DEC concurrently starting at Day 1 for selected cancers. Completed Cohort |
| INT 230-6 Combined With Ipilimumab (Cohort FEC) | EXPERIMENTAL | FEC: INT230-6 per the EC3 regimen combined with Yervoy (ipilimumab) dosed concurrently starting at Day 1 every 3 weeks for four treatments for selected cancer types. Completed Cohort anti-CTLA-4 antibody: The anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC. |
| 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 |
| anti-PD-1 antibody | BIOLOGICAL | The anti-PD-1 antibody will be added concomitantly with INT230-6 as noted in cohort DEC and DEC2 |
| anti-CTLA-4 antibody | BIOLOGICAL | The anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC |
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...
INT230-6 is an investigational small molecule cancer therapy developed by Intensity Therapeutics, Inc. (ticker: INTS). It is designed for direct intratumoral injection and is being studied in solid tumors, including soft tissue sarcoma and breast cancer. It remains in clinical development and is not approved for commercial use.
INT230-6 is being evaluated for the treatment of adults with soft tissue sarcomas. The INVINCIBLE-3 study compares intratumoral INT230-6 against United States standard of care in this population. The drug is investigational and has not been approved for sarcoma or any other indication.
INT230-6 is developed by Intensity Therapeutics, Inc., a company that trades under the ticker INTS. Intensity Therapeutics is the sponsor of the clinical program studying the agent in soft tissue sarcoma and other solid tumors.
INT230-6 is in Phase 3 clinical development. The INVINCIBLE-3 trial (NCT06263231) is a Phase 3 study in soft tissue sarcoma that is currently recruiting. An earlier Phase 1/2 safety study (NCT03058289) has been completed. The drug is investigational and not FDA approved.
INT230-6 has been studied in two clinical trials. NCT06263231, known as INVINCIBLE-3, is a recruiting Phase 3 trial comparing intratumoral INT230-6 to standard of care in soft tissue sarcoma across the United States, Canada, France, Germany, and Spain. NCT03058289 was a completed Phase 1/2 safety study in multiple solid tumor types.
Across its clinical program, INT230-6 trials have a combined enrollment of 333 participants. The Phase 3 INVINCIBLE-3 study (NCT06263231) plans to enroll 333 patients, while the completed Phase 1/2 study (NCT03058289) enrolled 111 participants. Both studies enrolled adults aged 18 years and older.