Clinical trial of safety and antitumor activity of farletuzumab ecteribulin in patients with platinum‐resistant ovarian cancer: Phase I expansion results
Bibliographic record
Abstract
OBJECTIVE: In the dose-escalation part of Study 101, which included multiple tumor types, objective responses were observed in 10 of 22 patients across multiple dose levels of farletuzumab ecteribulin (FZEC). We explored the safety/antitumor activity of FZEC in patients with platinum-resistant ovarian cancer (PROC) from the Study 101 expansion part. METHODS: Eligible patients were aged ≥20 years and received FZEC 0.9 or 1.2 mg/kg intravenously Q3W. Safety, objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were evaluated. Tumor assessments were performed by investigators per Response Evaluation Criteria in Solid Tumors version 1.1, and folate receptor-alpha (FRα) status of tumor samples was assessed by central immunohistochemistry. RESULTS: A total of 45 patients from Japan were treated. Among these patients, 24 were treated with FZEC 0.9 mg/kg and 21 with 1.2 mg/kg; 70.8% and 85.7% had FRα expression in ≥75% of neoplastic cells, respectively. Grade (Gr) ≥3 treatment-emergent adverse events were observed in nine patients (37.5%) in the 0.9 mg/kg group and in six (28.6%) in the 1.2 mg/kg group. Interstitial lung disease (ILD)/pneumonitis occurred in 37.5% (Gr ≥3: 0%) of the 0.9 mg/kg group and 66.7% (Gr ≥3: 4.8%) of the 1.2 mg/kg group. In the 0.9 and 1.2 mg/kg groups, ORR was 25.0 and 52.4%, median (m)DOR was 10.6 and 7.6 months, mPFS was 6.7 and 8.2 months, and mOS was 10.5 and 20.5 months, respectively. CONCLUSION: FZEC showed promising antitumor activity, and the observed adverse events were generally manageable, with the exception of ILD, in patients with PROC. GOV REGISTRATION: NCT03386942. URL: https://clinicaltrials.gov/study/NCT03386942.
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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 | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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 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".