677 A phase 1, open-label, dose escalation study of the safety and tolerability of ANK-101 in advanced solid tumors
Bibliographic record
Abstract
<h3>Background</h3> IL-12 is a cytokine that can stimulate both innate and adaptive tumor immunity. Clinical trials of systemic IL-12 have demonstrated anti-tumor activity, but potential efficacy has been markedly limited by significant systemic toxicity, including death. ANK-101 is an anchored immunotherapy that links IL-12 to aluminum hydroxide through an alum-binding protein (ABP). The ANK-101 complex anchors IL-12 in the tumor microenvironment (TME), resulting in prolonged local retention and low levels of systemic absorption. Preclinical studies in murine tumor models show that ANK-101 is retained at the injection site for up to 28 days, recruits and activates T and NK cells, promotes M1 myeloid cell differentiation, induces regression of both injected and un-injected tumors, and induces immunologic memory. <h3>Methods</h3> This first-in-human, open-label study aims to evaluate intratumoral ANK-101 in advanced solid malignancies in superficial (Part 1) and visceral (Part 2) tumors. Both parts have dose-escalation and expansion cohorts, with each enrolling 12–36 participants in dose escalation. The first three dose escalation cohorts for each part include single participant enrollment, followed by standard 3+3 dose escalation design. If no dose limiting toxicity (DLT) is observed, the dose level will be escalated until ≥1/3 or ≥2/6 patients experience a DLT. An additional ten patients will be enrolled at the recommended dose for expansion (RDE) in both Parts 1 and 2. Patients will be treated every 3 weeks for 4 cycles. Imaging or clinical assessments will be performed every 12 weeks in Part 1 and every 6 weeks in Part 2. If no significant clinical deterioration or unacceptable toxicity is apparent, patients may receive four additional cycles. Eligible participants must have an advanced solid malignancy that is refractory to standard treatment and accessible for injection and biopsy, measurable disease by RECIST v1.1, and ECOG PS of 0–1. Key exclusion criteria include tumors close to vital structures, uncontrolled bleeding disorders, and active autoimmune disease. Primary objectives include safety and tolerability and identification of the RDE. Secondary objectives include pharmacokinetics (PK) and immunogenicity (ADA) of ANK-101 and clinical activity measured by ORR, DCR, DOR, and PFS by RECIST v1.1. Exploratory objectives include QOL using FACT-G<sup>©</sup> and immune pharmacodynamic (PD) changes. PD assessments will include serum cytokines and circulating immune cells, and local levels of PD-L1, CD8+ T cells, and CD68+ macrophages, and changes in gene expression within the TME. This clinical trial is in progress. Clinical trial information: Clinical Trial Registry NCT06171750. Research Sponsor: Ankyra Therapeutics.
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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) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| 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".