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 machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".