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
Bibliographic record
Abstract
BACKGROUND: Systemic 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. METHODS: In 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. FINDINGS: No 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. INTERPRETATION: IT INT230-6 was well tolerated and manifested promising treatment benefits. FUNDING: Intensity Therapeutics, Inc.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".