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INT230-6

DRUG4 trials

Sponsors

Intensity Therapeutics, Inc., Ottawa Hospital Research Institute, Swiss Cancer Institute

Conditions

Bile Duct CancerBreast CancerChordoma of SacrumColon CancerHead and Neck CancerLiver CancerLung CancerLymphoma

Phase 1

A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6
CompletedNCT03058289
Intensity Therapeutics, Inc.Bile Duct Cancer, Breast Cancer, Chordoma of Sacrum +8
Start: 2017-02-09End: 2023-02-22Updated: 2025-02-27

Phase 2

INVINCIBLE TRIAL: Intratumoral INT230-6 in Breast Cancer
NCT04781725
Ottawa Hospital Research InstituteBreast Cancer
Start: 2021-03-25End: 2023-03-01Target: 90Updated: 2021-11-17
Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK
RecruitingNCT06358573
Swiss Cancer InstituteTNBC - Triple-Negative Breast Cancer, Triple-negative Breast Cancer
Start: 2024-10-24End: 2031-12-01Target: 61Updated: 2026-04-02

Phase 3

A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)
Active, not recruitingNCT06263231
Intensity Therapeutics, Inc.Sarcoma,Soft Tissue
Start: 2024-06-28End: 2028-12-31Target: 333Updated: 2025-07-29

Related Papers

Abstract PS4-10-15: Accelerating an Anthracycline-Free Future: A New Drug in Clinical Testing Offers Patients Hope for Safer, More Effective Breast Cancer Therapy Combinations
Clinical Cancer Research2026-02-17
Abstract PS5-08-16: Intratumoral Injections of INT230-6 Prior to Neoadjuvant Immuno-chemotherapy in Early-Stage Triple Negative Breast Cancer: Early observations from INVINCIBLE-4-SAKK 66/22 (NCT06358573), a Phase II Randomized Controlled Trial
Clinical Cancer Research2026-02-17
Safety and efficacy of intratumourally administered INT230-6 in adult patients with advanced solid tumours: results from an open-label phase 1/2 dose escalation study.
2025-10-29
Abstract P2-08-23: Evaluation of Pathological Complete Response & Immunomodulatory Effects Following Intratumoral Injection of INT230-6 Prior to Neoadjuvant Immuno-chemotherapy in Early-Stage Triple Negative Breast Cancer: A Phase II Study INVINCIBLE-4-SAKK 66/22
Clinical Cancer Research2025-06-13
A multicenter, randomized, global phase 3 study to assess the efficacy and safety of intratumoral (IT) INT230-6 (SHAO, vinblastine, cisplatin) as monotherapy compared with standard of care systemic chemotherapy in adults with locally recurrent, inoperable, or metastatic soft tissue sarcomas (STS; INVINCIBLE-3).
Journal of Clinical Oncology2025-05-28
Abstract PS16-03: 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
Cancer Research2024-05-02
Intratumoral INT230-6 (cisplatin, vinblastine, shao) alone or with ipilimumab prolonged survival with favorable safety in adults with refractory sarcomas.
Journal of Clinical Oncology2023-06-014 citations
Phase II randomized window of opportunity trial evaluating cytotoxic and immunomodulatory effects of intratumoral INT230-6 in early stage breast cancer: The INVINCIBLE trial.
Journal of Clinical Oncology2023-06-011 citations
Abstract P6-05-12: Understanding Patient Perspectives on Window of Opportunity Clinical Trial Participation in Breast Cancer
Cancer Research2023-03-01
Abstract PD11-02: PD11-02 A Phase II Randomized Window of Opportunity Trial Evaluating Cytotoxic and Immunomodulatory effects of Intratumoral INT230-6 in Early Stage Breast Cancer: the INVINCIBLE Trial
Cancer Research2023-03-01
710 Safety and survival results from a phase 1/2 trial of intratumoral agent INT230–6 (cisplatin vinblastine) induces immunological cancer cell death alone or with pembrolizumab in patients with refractory, metastatic cancers
Regular and Young Investigator Award Abstracts2022-11-01
545 A phase II randomized window of opportunity trial evaluating cytotoxic and immunomodulatory effects of intratumoral INT230-6 (cisplatin, vinblastine) in early stage breast cancer: the INVINCIBLE trial
Regular and Young Investigator Award Abstracts2022-11-01
Effect of intratumoral INT230-6 on tumor necrosis and promotion of a systemic immune response: Results from a multicenter phase 1/2 study of solid tumors with and without pembrolizumab (PEM) [Intensity IT-01; Merck KEYNOTE-A10].
Journal of Clinical Oncology2022-06-015 citations
Intratumoral (IT) INT230-6 can cause tumor necrosis in vivo: Preliminary results of a phase II randomized presurgical window-of-opportunity study in early breast cancers (the INVINCIBLE study).
Journal of Clinical Oncology2022-06-01
INT230-6 monotherapy and in combination with ipilimumab (IPI) across a broad spectrum of refractory soft tissue sarcomas (STS) [Intensity IT-01; BMS#CA184-592].
Journal of Clinical Oncology2022-06-01
501 Survival and immune response data from intratumoral INT230–6 alone (IT-01) and with pembrolizumab [KEYNOTE-A10] in subjects with locally advanced, unresectable and metastatic solid tumors
Regular and Young Investigator Award Abstracts2021-11-01
536 Intratumoral INT230–6 shows a favorable safety profile and early signs of efficacy in advanced soft tissue sarcoma with monotherapy and in combination with ipilimumab [Intensity IT-01; BMS#CA184–592]
Regular and Young Investigator Award Abstracts2021-11-01
Phase 1/2 trial evaluating intratumoral administration of INT230-6 alone and in combination with an anti-PD1 antibody for advanced malignancies.
Journal of Clinical Oncology2018-05-20