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INT230-6

Phase 3

Sarcoma,Soft Tissue | Small molecule | Oncology |Intensity Therapeutics, Inc.|Last Updated: Jul 29, 2025

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Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment333
FDA Designations
ORPHAN_DRUG
Clinical trial landscape

INT230-6 · 2 trials · 12 indications

Phase 3 1Phase 1 1
NCT06263231A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)Sarcoma,Soft Tissue
ACTIVE NOT_RECRUITING333 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)
Sarcoma,Soft TissueUnlock trial analytics
Study Endpoints
Primary Endpoints
Overall Survival (OS)
From date of randomization until the documented date of death from any cause for a period of up to 2 years, unless superiority is demonstrated sooner or 80% of deaths during the study period.

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.

Rate and Severity of Treatment-emergent Adverse Events ≥ Grade 3 Attributed to Study Drug Using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5)
Up to 5 years

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.

Secondary Endpoints
Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with leiomyosarcoma
From date of randomization until the documented date of death from any cause for a period of up to 2 years, unless superiority is demonstrated sooner or 80% of deaths during the study period.
Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with liposarcoma
From date of randomization until the documented date of death from any cause for a period of up to 2 years, unless superiority is demonstrated sooner or 80% of deaths during the study period.
Preliminary Efficacy: Assess the Preliminary Efficacy of INT230-6 by Measuring the Disease Control Rate (DCR) Based on the Response Evaluation Criteria in Solid Tumors (RECIST) and Immune RECIST (iRECIST) Criteria,
Up to 5 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
INT230-6 MonotherapyEXPERIMENTALINT230-6 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 CareACTIVE_COMPARATORParticipants 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)EXPERIMENTALDosing: \>=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)EXPERIMENTALDosing: \<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)EXPERIMENTALDEC: 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)EXPERIMENTALFEC: 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.
Interventions
NameTypeDescription
INT230-6DRUGINT230-6 is a fixed combination of cisplatin, vinblastine and SHAO.
EribulinDRUGEribulin IV
TrabectedinDRUGTrabectedin infusion
PazopanibDRUGPazopanib pill
anti-PD-1 antibodyBIOLOGICALThe anti-PD-1 antibody will be added concomitantly with INT230-6 as noted in cohort DEC and DEC2
anti-CTLA-4 antibodyBIOLOGICALThe anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

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...

Countries:United StatesCanadaFranceGermanySpain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06263231primaryCompletionDate: changed
LOWMay 24, 2026NCT06263231studyFirstPostDate: changed