Interleukin-12 anchored drug conjugate (tolododekin alfa) in patients with advanced solid tumors: first-in-human Phase 1 trial
Bibliographic record
Abstract
Anchored immunotherapy is a novel approach for retaining drugs within the tumour microenvironment. Tolododekin alfa is a first-in-class anchored Interleukin 12 (IL-12) linked to aluminum hydroxide. Safety and biological activity were evaluated in a Phase 1 clinical trial in patients with accessible advanced solid tumours in Part 1 of a 3-part trial. The primary objectives are safety and tolerability as well as determination of the recommended dose for expansion (RDE). Secondary objectives include pharmacokinetics (PK), pharmacodynamics, preliminary antitumour activity, and immunogenicity. Exploratory analyses include serum and tissue biomarkers. Fifteen patients were enrolled at escalating doses of tolododekin alfa given by injection every 3 weeks. There were no dose-limiting toxicities or treatment-related serious adverse events. PK/Pharmacodynamic measurements demonstrate retention of drug in the tumour. Biological activity demonstrates increased CD8+ T cells, Programmed Cell Death Ligand 1 (PD-L1) expression, and prolonged pro-inflammatory gene expression. Nine patients (60%) achieved stable disease with one partial response. At a median follow-up of 5.2 months, the median duration of stable disease was 5.3 months (range 3.6-7.6 months). Median progression-free survival (PFS) was not estimable (NE) (95% CI, 2.57 months – NE). These findings support continued clinical development of tolododekin alfa. ClinicalTrials.gov registration: NCT06171750. Tolododekin alfa is an anchored interleukin-12 conjugate enhancing tumour retention. Here, this group reports a Phase 1 trial evaluating the safety and biological activity of tolododekin alfa in patients with different advanced solid tumours.
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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 | 0.001 | 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".