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    DRUG:

    cisplatin/vinblastine/SHAO-FA (INT230-6)

    i
    Other names: INT230-6 , INT 230-6, INT230-6, PORT-1, cisplatin/vinblastine formulation with cell penetration enhancer
    Company:
    Intensity Therap
    Drug class:
    DNA synthesis inhibitor, Microtubule inhibitor, DNA cross linking agent, Apoptosis inhibitor
    Related drugs:
    4ms
    A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3) (clinicaltrials.gov)
    P3, N=333, Active, not recruiting, Intensity Therapeutics, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    pazopanib • Halaven (eribulin mesylate) • Yondelis (trabectedin) • cisplatin/vinblastine/SHAO-FA (INT230-6)
    1year
    Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK (clinicaltrials.gov)
    P2, N=54, Recruiting, Swiss Group for Clinical Cancer Research | Not yet recruiting --> Recruiting
    Enrollment open
    |
    carboplatin • doxorubicin hydrochloride • cisplatin/vinblastine/SHAO-FA (INT230-6)
    over1year
    Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK (clinicaltrials.gov)
    P2, N=54, Not yet recruiting, Swiss Group for Clinical Cancer Research | Initiation date: Jun 2024 --> Oct 2024
    Trial initiation date
    |
    carboplatin • doxorubicin hydrochloride • cisplatin/vinblastine/SHAO-FA (INT230-6)
    over1year
    A Study to Investigate Efficacy & Safety of INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3) (clinicaltrials.gov)
    P3, N=333, Recruiting, Intensity Therapeutics, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    pazopanib • Halaven (eribulin mesylate) • Yondelis (trabectedin) • cisplatin/vinblastine/SHAO-FA (INT230-6)
    over1year
    Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK (clinicaltrials.gov)
    P2, N=54, Not yet recruiting, Swiss Group for Clinical Cancer Research
    New P2 trial
    |
    carboplatin • doxorubicin hydrochloride • cisplatin/vinblastine/SHAO-FA (INT230-6)
    almost2years
    A Study to Investigate Efficacy & Safety of INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3) (clinicaltrials.gov)
    P3, N=333, Not yet recruiting, Intensity Therapeutics, Inc.
    New P3 trial • Metastases
    |
    pazopanib • Halaven (eribulin mesylate) • Yondelis (trabectedin) • cisplatin/vinblastine/SHAO-FA (INT230-6)
    2years
    Intratumoral dosing of INT230-6 in Early-Stage Breast Cancer Patients Induces Tumor Cell Necrosis and Immunomodulatory Effects: A Phase II Randomized Window-Of-Opportunity Study – the INVINCIBLE Trial (SABCS 2023)
    Preliminary evidence shows that a single dose of INT230-6 can cause significant intratumoral necrosis compared to saline especially in tumors >2. cm. INT230-6 stimulates an immune response in breast cancers prior to surgery with minimal adverse effects and good tolerability.
    Clinical • P2 data • IO biomarker • Immunomodulating • Tumor cell
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    cisplatin/vinblastine/SHAO-FA (INT230-6)
    over2years
    INTRATUMORAL INT230-6 (CISPLATIN, VINBLASTINE, SHAO) ALONE OR WITH IPILIMUMAB PROLONGED SURVIVAL WITH FAVORABLE SAFETY AND IMMUNE ACTIVATION IN ADULTS WITH REFRACTORY SARCOMAS (NCT 03058289) (CTOS 2023)
    INT230-6 use was associated with immune infiltration and a clinically relevant mOS particularly when ≥40% of the TTB was injected. Uninjected tumors shrank in a high percentage of monotherapy subjects. INT230-6 dosed IT alone or with IPI had favorable safety in diverse sarcomas.
    Clinical
    |
    CD4 (CD4 Molecule)
    |
    Yervoy (ipilimumab) • cisplatin/vinblastine/SHAO-FA (INT230-6)
    almost3years
    KEYNOTE-A10: A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6 (clinicaltrials.gov)
    P1/2, N=110, Completed, Intensity Therapeutics, Inc. | Active, not recruiting --> Completed | Trial completion date: Oct 2023 --> Feb 2023 | Trial primary completion date: Jul 2022 --> Feb 2023
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    MSI (Microsatellite instability)
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • cisplatin/vinblastine/SHAO-FA (INT230-6)
    over3years
    KEYNOTE-A10: A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6 (clinicaltrials.gov)
    P1/2, N=110, Active, not recruiting, Intensity Therapeutics, Inc. | Recruiting --> Active, not recruiting | N=180 --> 110
    Enrollment closed • Enrollment change
    |
    MSI (Microsatellite instability)
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • cisplatin/vinblastine/SHAO-FA (INT230-6)
    4years
    SAFETY AND EFFICACY FROM A PHASE 1/2 STUDY OF INTRATUMORAL INT230-6 ALONE OR IN COMBINATION WITH IPILIMUMAB [INTENSITY# IT-01; BMS# CA184-592] IN ADULT SUBJECTS WITH METASTATIC SARCOMAS (NCT 03058289) (CTOS 2021)
    Intratumoral INT230-6 appears well-tolerated in this heterogenous soft tissue sarcoma population, and early safety with the IPI combination appears favorable. INT230-6 monotherapy treatment resulted in encouraging signs of tumor burden reduction in injected and non-injected lesions, and immune activation. Given the poor cor- 93 relation of RECIST responses and OS in this population, preliminary analysis of OS from this study compares favorably to historical results from a P1/2 basket sarcoma study with a similar, heavily pretreated, heterogeneous sarcoma population balanced for three prognostic health criteria: albumin and lactase dehydrogenase levels and a subject’s number of metastatic sites.
    Clinical • P1/2 data • Combination therapy
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    Yervoy (ipilimumab) • cisplatin/vinblastine/SHAO-FA (INT230-6)
    4years
    INVINCIBLE TRIAL: Intratumoral INT230-6 in Breast Cancer (clinicaltrials.gov)
    P2, N=90, Recruiting, Ottawa Hospital Research Institute | N=60 --> 90
    Clinical • Enrollment change
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    cisplatin/vinblastine/SHAO-FA (INT230-6)