Safety, tolerability, and pharmacokinetics of ASP1235 in relapsed or refractory acute myeloid leukemia: A phase 1 study
Bibliographic record
Abstract
Acute myeloid leukemia (AML) is an aggressive hematologic malignancy. Although new agents including targeted therapies for relapsed or refractory (R/R) AML have been introduced, poor outcomes remain, requiring the need for novel approaches. One novel approach is the use of antibody-drug conjugates (ADCs). We conducted an early phase clinical trial with ASP1235, an ADC targeting FMS-like tyrosine kinase 3. In total, 43 patients with R/R AML were treated with ASP1235. The most common adverse events (AEs) included elevated liver transaminase levels, ocular toxicity, and muscular weakness. Ocular treatment-emergent AEs (TEAEs) were observed in 53 % of patients; most were mild or moderate in severity. The most common ocular TEAEs were blurred vision, dry eye, keratitis, photophobia, and reduced visual acuity. Serious (grade ≥3) ocular TEAEs occurred in 16.3 % of patients, with only 1 patient experiencing grade 4 keratitis. Six patients achieved composite complete remission (complete remission [CR] + CR with incomplete hematologic recovery + CR with incomplete platelet recovery), 2 of whom proceeded to hematopoietic cell transplantation with long-term leukemia-free survival. This trial was registered at www.clinicaltrials.gov as #NCT02864290.
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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 | 0.006 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.002 | 0.004 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.001 | 0.004 |
| Insufficient payload (model declined to judge) | 0.001 | 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".