{"id":"int230-6","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Chills"},{"rate":null,"effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL13178","moleculeType":"Small molecule","molecularWeight":"378.47"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"INT230-6 consists of a CpG oligonucleotide (TLR9 agonist) combined with doxorubicin in a single formulation designed for intratumoral injection. The TLR9 agonist activates dendritic cells and other immune cells, while doxorubicin provides direct cytotoxic effects and immunogenic cell death, together generating a systemic anti-tumor immune response.","oneSentence":"INT230-6 is a dual-acting immunotherapy that combines a TLR9 agonist with doxorubicin to activate innate immunity and promote anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:16:22.453Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Melanoma (intratumoral injection)"},{"name":"Head and neck squamous cell carcinoma (intratumoral injection)"},{"name":"Merkel cell carcinoma (intratumoral injection)"}]},"trialDetails":[{"nctId":"NCT06263231","phase":"PHASE3","title":"A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Intensity Therapeutics, Inc.","startDate":"2024-06-28","conditions":"Sarcoma,Soft Tissue","enrollment":333},{"nctId":"NCT06358573","phase":"PHASE2","title":"Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK","status":"RECRUITING","sponsor":"Swiss Cancer Institute","startDate":"2024-10-24","conditions":"Triple-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer","enrollment":54},{"nctId":"NCT03058289","phase":"PHASE1, PHASE2","title":"A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6","status":"COMPLETED","sponsor":"Intensity Therapeutics, Inc.","startDate":"2017-02-09","conditions":"Breast Cancer, Head and Neck Cancer, Squamous Cell Carcinoma","enrollment":111},{"nctId":"NCT04781725","phase":"PHASE2","title":"INVINCIBLE TRIAL: Intratumoral INT230-6 in Breast Cancer","status":"UNKNOWN","sponsor":"Ottawa Hospital Research Institute","startDate":"2021-03-25","conditions":"Breast Cancer","enrollment":90}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Cisplatin","Vinblastine","2-hydroxybenzoylaminooctanoate (SAHO)"],"phase":"phase_3","status":"active","brandName":"INT230-6","genericName":"INT230-6","companyName":"Intensity Therapeutics, Inc.","companyId":"intensity-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"INT230-6 is a dual-acting immunotherapy that combines a TLR9 agonist with doxorubicin to activate innate immunity and promote anti-tumor immune responses. Used for Melanoma (intratumoral injection), Head and neck squamous cell carcinoma (intratumoral injection), Merkel cell carcinoma (intratumoral injection).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":2,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}