Trial reportEBioMedicine2025
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.
Trial report in EBioMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03058289 (A Phase 1/2 Safety Study of Intratumorally Administered INT230-6 in Adult Subjects With Advanced Refractory Cancers), which is not on this map. Cited by 3 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1/2 Safety Study of Intratumorally Administered INT230-6 in Adult Subjects With Advanced Refractory Cancers
Who cites it
3 citing papers in PubMed.
- Hybrid Non-Informative and Informative Prior Model-Assisted Designs for Mid-Trial Dose Insertion.Statistics in medicine · 2026Article
- Ultrasmall Ligand-Protected AgACS nano · 2026Article
- The Role of CD4Cells · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSystemic chemotherapeutics have limited efficacy in many advanced solid tumours. This study evaluated the safety and tolerability of INT230-6, a unique intratumoural (IT) formulation of cisplatin, vinblastine, and 8-((2-hydroxybenzoyl)amino)octanoate (SHAO), an amphiphilic cell-penetration enhancer.
methodsIn this single-arm phase 1/2 trial (NCT03058289), adults with advanced or metastatic disease who progressed on a median of three prior therapies received multiple doses of IT INT230-6 monotherapy once every 28 days or biweekly for five treatments with maintenance dosing every 9 weeks. INT230-6 dose was based on tumour diameter or volume and escalated across five cohorts. A fixed-dose cohort received up to 175 mL.
findingsNo dose-limiting toxicities were reported among 64 enrolled patients; seven (10·9%) discontinued treatment due to adverse events (AEs). Overall, 52/64 (81·3%) patients had treatment-related AEs (TRAEs), including grade ≥3 TRAEs (7/64 [10·9%]) and serious TRAEs (3/64 [4·7%]). INT230-6 achieved a disease control rate (DCR) of 75% (48/64 patients) and median overall survival (mOS) of 11·9 months (95% confidence interval [CI]: 6·3-19·4). In an exploratory analysis, patients dosed at ≥40% of total tumour burden vs <40% had improved DCR (40/48 [83·3%] vs 8/16 [50%]) and mOS (18·7 months [95% CI: 11·5-23·5] vs 3·1 months [95% CI: 1·6-5·9]). Fifteen patients survived ≥21 months; eight were alive at study end. INT230-6 induced a qualitative decrease in proliferating cancer cells in injected tumours and a qualitative increase in activated T-cells infiltrating the tumour microenvironment. Ten patients had abscopal responses.
interpretationIT INT230-6 was well tolerated and manifested promising treatment benefits.
fundingIntensity Therapeutics, Inc.
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